<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413552</url>
  </required_header>
  <id_info>
    <org_study_id>INDV-2000-101</org_study_id>
    <nct_id>NCT04413552</nct_id>
  </id_info>
  <brief_title>INDV-2000 First in Human</brief_title>
  <official_title>A Phase I, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indivior Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indivior Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated&#xD;
      dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable&#xD;
      safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will&#xD;
      be conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Actual">April 13, 2021</completion_date>
  <primary_completion_date type="Actual">April 13, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Part I - sequential escalating dose cohorts; within each dose cohort participants will be randomized to INDV-2000 or matching placebo in a 3:1 ratio.&#xD;
Part II - single cohort crossover study in which participants will receive INDV-2000 on 2 occasions separated by a 1-week washout period, once under fasting conditions and once after a standard high-fat breakfast.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Part I: Double-blind;&#xD;
Part II: Open-label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
    <description>An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors.&#xD;
A serious AE is any event that met any of the following criteria:&#xD;
Death&#xD;
Life-threatening&#xD;
In-patient hospitalization or prolongation of existing hospitalization&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome.&#xD;
A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Findings</measure>
    <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
    <description>The investigator assessed abnormal laboratory values to determine clinical significance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Vital Signs</measure>
    <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
    <description>The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings</measure>
    <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
    <description>The investigator assessed abnormal ECG values to determine clinical significance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Physical Examination Findings</measure>
    <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
    <description>Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
    <description>Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
    <description>Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000</measure>
    <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</measure>
    <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Part I: INDV-2000</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part I: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a single dose of matching placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part II: INDV-2000 Fasted/Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INDV-2000</intervention_name>
    <description>INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.</description>
    <arm_group_label>Part I: INDV-2000</arm_group_label>
    <arm_group_label>Part II: INDV-2000 Fasted/Fed</arm_group_label>
    <other_name>C4X_3256</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.</description>
    <arm_group_label>Part I: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be able to verbalize understanding the consent form, able to provide written&#xD;
             informed consent, and verbalize willingness to complete study procedures, and be able&#xD;
             to comply with protocol requirements, rules and regulations of the study site, and be&#xD;
             likely to complete all the study interventions.&#xD;
&#xD;
          -  Must be considered a healthy male or non-childbearing female for Part I&#xD;
&#xD;
          -  For Part II, must be a healthy male who did not participate in Part I and willing to&#xD;
             consume a high-fat meal.&#xD;
&#xD;
          -  Body mass index (BMI) within 18.0 to 30.0 kg/m^2, inclusive (minimum weight of at&#xD;
             least 50.0 kg at Screening)&#xD;
&#xD;
          -  Male subjects who are sexually active with female partners of child-bearing potential&#xD;
             must use, with their partner, a condom plus an approved method of effective&#xD;
             contraception from time of screening until 90 days after last dose of Investigational&#xD;
             Medicinal Product (IMP). Additionally, male subjects must agree to not donate sperm&#xD;
             during the study and for at least 90 days from last dose of IMP.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a medical history of clinically significant neurological, cardiovascular, renal,&#xD;
             hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as&#xD;
             judged by an Investigator,&#xD;
&#xD;
          -  Have clinically significant abnormal biochemistry, hematology or urinalysis results as&#xD;
             judged by an Investigator,&#xD;
&#xD;
          -  Have a history of narcolepsy or other significant sleep disorders&#xD;
&#xD;
          -  Have disorders that may interfere with drug absorption, distribution, metabolism and&#xD;
             excretion (ADME) processes,&#xD;
&#xD;
          -  Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies,&#xD;
             hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).&#xD;
&#xD;
          -  Serious cardiac illness or other medical condition including, but not limited to:&#xD;
             Uncontrolled arrhythmias; History of congestive heart failure (CHF); myocardial&#xD;
             infarction &lt; 6 months from receipt of first dose of IMP; uncontrolled symptomatic&#xD;
             angina; corrected QT value (QTcF) &gt; 450 msec for males and &gt; 470 msec for females or&#xD;
             history of prolonged QT syndrome; Have a blood pressure reading outside of the&#xD;
             following range: systolic &lt; 86 or &gt; 149 mmHg; diastolic &lt; 50 or &gt; 94 mmHg&#xD;
&#xD;
          -  Current active hepatic or biliary disease. Subjects with cholecystectomy &lt; 90 days&#xD;
             prior to screening.&#xD;
&#xD;
          -  Regular alcohol consumption in males &gt; 21 units per week and females &gt; 14 units per&#xD;
             week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).&#xD;
&#xD;
          -  Positive test result for alcohol and/or drugs of abuse at screening or prior to the&#xD;
             first IMP administration.&#xD;
&#xD;
          -  Current smokers and those who have smoked within the last 90 days. Current users of&#xD;
             e-cigarettes and nicotine replacement products, and those who have used these products&#xD;
             within the last 90 days.&#xD;
&#xD;
          -  Concurrent treatment or treatment with an investigational drug within 30 days prior to&#xD;
             the first dose.&#xD;
&#xD;
          -  Blood donation of approximately 500 mL within 56 days or plasma donation within 7 days&#xD;
             of screening.&#xD;
&#xD;
          -  Subjects who are taking, or have taken, any prescribed or over-the-counter drugs&#xD;
             (other than 2 g per day acetaminophen, hormone replacement therapy, hormonal&#xD;
             contraception) or herbal remedies in the 14 days before IMP administration. Exceptions&#xD;
             may apply on a case by case basis if considered not to interfere with the objectives&#xD;
             of the study, as agreed by an Investigator and Sponsor's Medical Monitor.&#xD;
&#xD;
          -  Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges&#xD;
             within 7 days prior to the IMP administration&#xD;
&#xD;
          -  Treatment with any known drugs that are moderate or strong inhibitors/inducers of&#xD;
             cytochrome P450 (CYP) 3A4 within 30 days prior to first dose of IMP.&#xD;
&#xD;
          -  Known allergy or hypersensitivity to IMP or its excipients.&#xD;
&#xD;
          -  Any condition that, in the opinion of an Investigator, would interfere with evaluation&#xD;
             of the IMP or interpretation of subject safety or study results.&#xD;
&#xD;
          -  Affiliated with, or a family member of, site staff directly involved in the study, or&#xD;
             anyone with a financial interest in the outcome of the study.&#xD;
&#xD;
          -  Subjects who are unable, in the opinion of an Investigator, to comply fully with the&#xD;
             study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Kankam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Altasciences Company Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Altasciences Clinical Kansas</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <results_first_submitted>August 19, 2022</results_first_submitted>
  <results_first_submitted_qc>September 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2022</results_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04413552/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04413552/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT04413552/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy volunteers were enrolled at a single site in Overland Park, Kansas, United States.</recruitment_details>
      <pre_assignment_details>This study was conducted in 2 parts: Part I was a double-blind, placebo-controlled, randomized, single ascending dose (SAD) study in which participants were randomized in cohorts of 8 subjects with 6 subjects receiving active drug and 2 subjects receiving placebo. Part II was an open-label, cross-over, food interaction, single-dose study with INDV-2000 administered once under fasting conditions and once after completion of a standard high-fat breakfast.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part I: INDV-2000 1 mg</title>
          <description>Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Part I: INDV-2000 5 mg</title>
          <description>Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P3">
          <title>Part I: INDV-2000 20 mg</title>
          <description>Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P4">
          <title>Part I: INDV-2000 50 mg</title>
          <description>Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P5">
          <title>Part I: INDV-2000 120 mg</title>
          <description>Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P6">
          <title>Part I: INDV-2000 180 mg</title>
          <description>Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P7">
          <title>Part I: INDV-2000 360 mg</title>
          <description>Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P8">
          <title>Part I: INDV-2000 720 mg</title>
          <description>Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P9">
          <title>Part I: Pooled Placebo</title>
          <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="P10">
          <title>Part II: INDV-2000 360 mg Fasted/Fed</title>
          <description>Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="16"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="16"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="16"/>
                <participants group_id="P10" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Part I: INDV-2000 1 mg</title>
          <description>Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Part I: INDV-2000 5 mg</title>
          <description>Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Part I: INDV-2000 20 mg</title>
          <description>Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B4">
          <title>Part I: INDV-2000 50 mg</title>
          <description>Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B5">
          <title>Part I: INDV-2000 120 mg</title>
          <description>Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B6">
          <title>Part I: INDV-2000 180 mg</title>
          <description>Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B7">
          <title>Part I: INDV-2000 360 mg</title>
          <description>Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B8">
          <title>Part I: INDV-2000 720 mg</title>
          <description>Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B9">
          <title>Part I: Pooled Placebo</title>
          <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="B10">
          <title>Part II: INDV-2000 360 mg Fasted/Fed</title>
          <description>Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8.</description>
        </group>
        <group group_id="B11">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="16"/>
            <count group_id="B10" value="8"/>
            <count group_id="B11" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Demographic data are reported separately for Part I and Part II.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Part I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="6"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="16"/>
                    <count group_id="B10" value="0"/>
                    <count group_id="B11" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.0" spread="12.05"/>
                    <measurement group_id="B2" value="42.2" spread="12.80"/>
                    <measurement group_id="B3" value="34.3" spread="4.41"/>
                    <measurement group_id="B4" value="40.5" spread="10.93"/>
                    <measurement group_id="B5" value="33.5" spread="11.20"/>
                    <measurement group_id="B6" value="31.5" spread="12.36"/>
                    <measurement group_id="B7" value="44.3" spread="6.74"/>
                    <measurement group_id="B8" value="31.8" spread="11.34"/>
                    <measurement group_id="B9" value="36.5" spread="11.49"/>
                    <measurement group_id="B11" value="37.3" spread="11.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="0"/>
                    <count group_id="B10" value="8"/>
                    <count group_id="B11" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B10" value="40.4" spread="7.52"/>
                    <measurement group_id="B11" value="40.4" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="6"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="16"/>
                    <count group_id="B10" value="8"/>
                    <count group_id="B11" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="13"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="6"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="16"/>
                    <count group_id="B10" value="8"/>
                    <count group_id="B11" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="15"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="6"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="6"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="16"/>
                    <count group_id="B10" value="8"/>
                    <count group_id="B11" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="7"/>
                    <measurement group_id="B10" value="4"/>
                    <measurement group_id="B11" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors.&#xD;
A serious AE is any event that met any of the following criteria:&#xD;
Death&#xD;
Life-threatening&#xD;
In-patient hospitalization or prolongation of existing hospitalization&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome.&#xD;
A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.</description>
        <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
        <population>Participants who received at least one dose of study drug (safety population)</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part I: Pooled Placebo</title>
            <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O10">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors.&#xD;
A serious AE is any event that met any of the following criteria:&#xD;
Death&#xD;
Life-threatening&#xD;
In-patient hospitalization or prolongation of existing hospitalization&#xD;
Persistent or significant disability/incapacity&#xD;
Congenital anomaly/birth defect&#xD;
Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome.&#xD;
A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.</description>
          <population>Participants who received at least one dose of study drug (safety population)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any treatment-emergent adverse event (TEAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-emergent serious adverse events (TESAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE with grade 3 or higher toxicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Findings</title>
        <description>The investigator assessed abnormal laboratory values to determine clinical significance.</description>
        <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
        <population>Participants who received at least one dose of study drug (safety population)</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part I: Pooled Placebo</title>
            <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O10">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Findings</title>
          <description>The investigator assessed abnormal laboratory values to determine clinical significance.</description>
          <population>Participants who received at least one dose of study drug (safety population)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes in Vital Signs</title>
        <description>The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.</description>
        <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
        <population>Participants who received at least one dose of study drug (safety population)</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part I: Pooled Placebo</title>
            <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O10">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in Vital Signs</title>
          <description>The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.</description>
          <population>Participants who received at least one dose of study drug (safety population)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings</title>
        <description>The investigator assessed abnormal ECG values to determine clinical significance.</description>
        <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
        <population>Participants who received at least one dose of study drug (safety population)</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part I: Pooled Placebo</title>
            <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O10">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings</title>
          <description>The investigator assessed abnormal ECG values to determine clinical significance.</description>
          <population>Participants who received at least one dose of study drug (safety population)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="16"/>
                <count group_id="O10" value="8"/>
                <count group_id="O11" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Physical Examination Findings</title>
        <description>Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.</description>
        <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
        <population>Clinically significant physical examination findings were not recorded separately.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O9">
            <title>Part I: Pooled Placebo</title>
            <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O10">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O11">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Physical Examination Findings</title>
          <description>Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.</description>
          <population>Clinically significant physical examination findings were not recorded separately.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose</title>
        <description>Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.</description>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters (PK population).</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose</title>
          <description>Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.</description>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters (PK population).</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="3.93"/>
                    <measurement group_id="O2" value="87.6" spread="26.4"/>
                    <measurement group_id="O3" value="194" spread="33.3"/>
                    <measurement group_id="O4" value="489" spread="147"/>
                    <measurement group_id="O5" value="1000" spread="343"/>
                    <measurement group_id="O6" value="1100" spread="238"/>
                    <measurement group_id="O7" value="1880" spread="1140"/>
                    <measurement group_id="O8" value="2080" spread="688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.58" upper_limit="2.08"/>
                    <measurement group_id="O2" value="0.50" lower_limit="0.50" upper_limit="1.15"/>
                    <measurement group_id="O3" value="2.50" lower_limit="1.00" upper_limit="3.05"/>
                    <measurement group_id="O4" value="2.02" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="1.00" upper_limit="2.00"/>
                    <measurement group_id="O6" value="3.50" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O7" value="2.00" lower_limit="2.00" upper_limit="3.00"/>
                    <measurement group_id="O8" value="3.00" lower_limit="2.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3" spread="17.7"/>
                    <measurement group_id="O2" value="312" spread="181"/>
                    <measurement group_id="O3" value="915" spread="186"/>
                    <measurement group_id="O4" value="2340" spread="1020"/>
                    <measurement group_id="O5" value="6900" spread="4050"/>
                    <measurement group_id="O6" value="8520" spread="1600"/>
                    <measurement group_id="O7" value="17800" spread="9800"/>
                    <measurement group_id="O8" value="28700" spread="7810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.5" spread="19.1"/>
                    <measurement group_id="O2" value="317" spread="180"/>
                    <measurement group_id="O3" value="907" spread="207"/>
                    <measurement group_id="O4" value="2350" spread="1030"/>
                    <measurement group_id="O5" value="6920" spread="4060"/>
                    <measurement group_id="O6" value="8530" spread="1590"/>
                    <measurement group_id="O7" value="17800" spread="9810"/>
                    <measurement group_id="O8" value="28700" spread="7810"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" spread="4.31"/>
                    <measurement group_id="O2" value="18.8" spread="6.98"/>
                    <measurement group_id="O3" value="23.2" spread="6.70"/>
                    <measurement group_id="O4" value="24.5" spread="9.67"/>
                    <measurement group_id="O5" value="22.4" spread="11.7"/>
                    <measurement group_id="O6" value="21.7" spread="4.03"/>
                    <measurement group_id="O7" value="25.8" spread="13.4"/>
                    <measurement group_id="O8" value="26.7" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="0.32"/>
                    <measurement group_id="O2" value="2.52" spread="0.46"/>
                    <measurement group_id="O3" value="2.56" spread="0.37"/>
                    <measurement group_id="O4" value="2.81" spread="0.47"/>
                    <measurement group_id="O5" value="3.56" spread="1.18"/>
                    <measurement group_id="O6" value="3.47" spread="0.46"/>
                    <measurement group_id="O7" value="4.57" spread="0.58"/>
                    <measurement group_id="O8" value="5.28" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000</title>
        <description>Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.</description>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000</title>
          <description>Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.</description>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="3.31"/>
                    <measurement group_id="O2" value="76.4" spread="14.4"/>
                    <measurement group_id="O3" value="182" spread="34.0"/>
                    <measurement group_id="O4" value="372" spread="113"/>
                    <measurement group_id="O5" value="983" spread="121"/>
                    <measurement group_id="O6" value="963" spread="326"/>
                    <measurement group_id="O7" value="1650" spread="536"/>
                    <measurement group_id="O8" value="1840" spread="318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="1.00" upper_limit="2.08"/>
                    <measurement group_id="O2" value="0.50" lower_limit="0.50" upper_limit="1.15"/>
                    <measurement group_id="O3" value="3.50" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.52" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="3.00" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="4.00" upper_limit="6.00"/>
                    <measurement group_id="O7" value="3.00" lower_limit="2.00" upper_limit="8.00"/>
                    <measurement group_id="O8" value="3.00" lower_limit="3.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="28.8"/>
                    <measurement group_id="O2" value="413" spread="223"/>
                    <measurement group_id="O3" value="1300" spread="489"/>
                    <measurement group_id="O4" value="3190" spread="2250"/>
                    <measurement group_id="O5" value="10000" spread="4370"/>
                    <measurement group_id="O6" value="10100" spread="5540"/>
                    <measurement group_id="O7" value="24000" spread="16200"/>
                    <measurement group_id="O8" value="25800" spread="6120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" spread="30.3"/>
                    <measurement group_id="O2" value="417" spread="222"/>
                    <measurement group_id="O3" value="1310" spread="489"/>
                    <measurement group_id="O4" value="3200" spread="2240"/>
                    <measurement group_id="O5" value="10100" spread="4370"/>
                    <measurement group_id="O6" value="10100" spread="5540"/>
                    <measurement group_id="O7" value="24000" spread="16200"/>
                    <measurement group_id="O8" value="25800" spread="6110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000</title>
        <time_frame>Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: INDV-2000 1 mg</title>
            <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Part I: INDV-2000 5 mg</title>
            <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Part I: INDV-2000 20 mg</title>
            <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O4">
            <title>Part I: INDV-2000 50 mg</title>
            <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O5">
            <title>Part I: INDV-2000 120 mg</title>
            <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O6">
            <title>Part I: INDV-2000 180 mg</title>
            <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O7">
            <title>Part I: INDV-2000 360 mg</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
          <group group_id="O8">
            <title>Part I: INDV-2000 720 mg</title>
            <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000</title>
          <population>Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" spread="0.84"/>
                    <measurement group_id="O2" value="4.04" spread="0.73"/>
                    <measurement group_id="O3" value="3.93" spread="0.50"/>
                    <measurement group_id="O4" value="4.23" spread="1.21"/>
                    <measurement group_id="O5" value="4.51" spread="0.81"/>
                    <measurement group_id="O6" value="4.45" spread="0.56"/>
                    <measurement group_id="O7" value="5.54" spread="1.07"/>
                    <measurement group_id="O8" value="5.87" spread="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1700" spread="584"/>
                    <measurement group_id="O2" value="2720" spread="796"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="3.00" lower_limit="1.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18200" spread="6060"/>
                    <measurement group_id="O2" value="16700" spread="7970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19700" spread="7690"/>
                    <measurement group_id="O2" value="17400" spread="8130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>L/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" spread="9.61"/>
                    <measurement group_id="O2" value="24.1" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.37" spread="1.62"/>
                    <measurement group_id="O2" value="2.91" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1320" spread="243"/>
                    <measurement group_id="O2" value="1500" spread="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="2.00" upper_limit="6.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="2.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15800" spread="4180"/>
                    <measurement group_id="O2" value="15000" spread="3920"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>ng*hr/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18200" spread="4030"/>
                    <measurement group_id="O2" value="15800" spread="4300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
        <time_frame>Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose</time_frame>
        <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
        <group_list>
          <group group_id="O1">
            <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part II Period 2: INDV-2000 360 mg Fed</title>
            <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
          </group>
        </group_list>
        <measure>
          <title>Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions</title>
          <population>The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.43" spread="1.13"/>
                    <measurement group_id="O2" value="5.21" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).</time_frame>
      <desc>All-cause mortality is reported for all randomized (in Part I) and enrolled (Part II) participants. Adverse events are reported for all participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part I: INDV-2000 1 mg</title>
          <description>Participants received a single dose of 1 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Part I: INDV-2000 5 mg</title>
          <description>Participants received a single dose of 5 mg INDV-2000 oral solution formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E3">
          <title>Part I: INDV-2000 20 mg</title>
          <description>Participants received a single dose of 20 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E4">
          <title>Part I: INDV-2000 50 mg</title>
          <description>Participants received a single dose of 50 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E5">
          <title>Part I: INDV-2000 120 mg</title>
          <description>Participants received a single dose of 120 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E6">
          <title>Part I: INDV-2000 180 mg</title>
          <description>Participants received a single dose of 180 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E7">
          <title>Part I: INDV-2000 360 mg</title>
          <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E8">
          <title>Part I: INDV-2000 720 mg</title>
          <description>Participants received a single dose of 720 mg INDV-2000 oral capsule formulation under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E9">
          <title>Part I: Pooled Placebo</title>
          <description>Participants received a single dose of matching placebo orally under fasted conditions on Day 1.</description>
        </group>
        <group group_id="E10">
          <title>Part II Period 1: INDV-2000 360 mg Fasted</title>
          <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 1 under fasted conditions.</description>
        </group>
        <group group_id="E11">
          <title>Part II Period 2: INDV-2000 360 mg Fed</title>
          <description>Participants received a single dose of 360 mg INDV-2000 oral capsule formulation on Day 8 after a high-fat breakfast.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (23.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI will not disseminate, present or publish any of the study data without the prior written approval from Indivior to do so.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Director, Clinical Development</name_or_title>
      <organization>Indivior, Inc.</organization>
      <phone>804-594-4488</phone>
      <email>TrialDisclosure@Indivior.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413552
org study id: INDV-2000-101
nct id: NCT04413552
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated
      dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable
      safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will
      be conducted.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Part I - sequential escalating dose cohorts; within each dose cohort participants will be randomized to INDV-2000 or matching placebo in a 3:1 ratio.
Part II - single cohort crossover study in which participants will receive INDV-2000 on 2 occasions separated by a 1-week washout period, once under fasting conditions and once after a standard high-fat breakfast.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Part I: Double-blind;
Part II: Open-label
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
description: An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors.
A serious AE is any event that met any of the following criteria:
Death
Life-threatening
In-patient hospitalization or prolongation of existing hospitalization
Persistent or significant disability/incapacity
Congenital anomaly/birth defect
Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome.
A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
measure: Number of Participants With Clinically Significant Laboratory Findings
time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
description: The investigator assessed abnormal laboratory values to determine clinical significance.
measure: Number of Participants With Clinically Significant Changes in Vital Signs
time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
description: The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
description: The investigator assessed abnormal ECG values to determine clinical significance.
measure: Number of Participants With Clinically Significant Physical Examination Findings
time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
description: Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.
measure: Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
description: Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.
measure: Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
description: Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.
measure: Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000
time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
measure: Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
arm group label: Part I: INDV-2000
arm group type: Experimental
description: Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics.
arm group label: Part I: Placebo
arm group type: Placebo Comparator
description: Participants will receive a single dose of matching placebo.
arm group label: Part II: INDV-2000 Fasted/Fed
arm group type: Experimental
description: Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I.
intervention type: Drug
intervention name: INDV-2000
description: INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.
arm group label: Part I: INDV-2000
arm group label: Part II: INDV-2000 Fasted/Fed
other name: C4X_3256
intervention type: Drug
intervention name: Placebo
description: Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.
arm group label: Part I: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Martin Kankam
role: Principal Investigator
affiliation: Altasciences Company Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 