xml: <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/NCT05995249</url>
    </required_header>
    <id_info>
      <org_study_id>TAK-279-1002</org_study_id>
      <nct_id>NCT05995249</nct_id>
    </id_info>
    <brief_title>A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults</brief_title>
    <official_title>A Phase 1, 3-Part, Open-label, Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor, and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Takeda</source>
    <oversight_info>
      <has_dmc>No</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>
        The main aim of this study is to find out how the body of a healthy adult processes TAK-279&#xD;
        (pharmacokinetics) when substances that either hinder or help the human metabolism such as&#xD;
        erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn&#xD;
        about side effects and how well it is tolerated when TAK-279 is given alone and together with&#xD;
        substances that impact human metabolism.&#xD;
  &#xD;
        The participants will need to stay at the clinic for up to 26 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the&#xD;
        effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part&#xD;
        2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in&#xD;
        healthy participants.&#xD;
  &#xD;
        The study will enroll approximately 48 patients. Participants will be enrolled in one of the&#xD;
        three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with&#xD;
        multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:&#xD;
  &#xD;
          -  Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg&#xD;
  &#xD;
          -  Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg&#xD;
  &#xD;
          -  Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg&#xD;
  &#xD;
        All participants will be monitored for up to 14 days postdose in each Part. Based on an&#xD;
        evaluation of the results from Parts 1 and 2, participants will be enrolled for Part 3.&#xD;
  &#xD;
        This single-center trial will be conducted in the United States. The overall study duration&#xD;
        is approximately 58 days for Part 1, 66 days for Part 2, and 63 days for Part 3.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 11, 2023</start_date>
    <completion_date type="Anticipated">November 9, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 9, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279</measure>
      <time_frame>Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279</measure>
      <time_frame>Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279</measure>
      <time_frame>Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part 2 and Part 3: Number of Participants with Suicidal Ideation as per the Columbia-suicide Severity Rating Scale (C-SSRS)</measure>
      <time_frame>Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3</time_frame>
      <description>The C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs</measure>
      <time_frame>From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)</time_frame>
      <description>Abnormal vital sign assessment will include assessments of systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as determined by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings</measure>
      <time_frame>From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)</time_frame>
      <description>Abnormal 12-lead ECG findings will include heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position as determined by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values</measure>
      <time_frame>From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)</time_frame>
      <description>Abnormal laboratory investigation will include hematology, chemistry, and urinalysis analysis as determined by the investigator.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TAK-279</intervention_name>
      <description>TAK-279 capsules</description>
      <arm_group_label>Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg</arm_group_label>
      <arm_group_label>Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg</arm_group_label>
      <arm_group_label>Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Erythromycin</intervention_name>
      <description>Erythromycin tablets</description>
      <arm_group_label>Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Phenytoin</intervention_name>
      <description>Phenytoin capsules</description>
      <arm_group_label>Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Efavirenz</intervention_name>
      <description>Efavirenz tablets</description>
      <arm_group_label>Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Understands the study procedures in the informed consent form (ICF), and be willing&#xD;
               and able to comply with the protocol.&#xD;
  &#xD;
            2. Healthy, adult, male or female of non-childbearing potential, 18-55 years of age,&#xD;
               inclusive, at the screening visit.&#xD;
  &#xD;
            3. Male participants must follow protocol specified contraception guidance.&#xD;
  &#xD;
            4. Continuous non-smoker who has not used nicotine- and tobacco-containing products for&#xD;
               at least 3 months prior to the first dosing based on participant self-reporting.&#xD;
  &#xD;
            5. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2 at the screening visit.&#xD;
  &#xD;
            6. Medically healthy with no clinically significant medical history, physical&#xD;
               examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as&#xD;
               deemed by the Investigator or designee, including the following:&#xD;
  &#xD;
                 -  Seated blood pressure (BP) is ≥ 90/40 millimeter of mercury (mmHg) and ≤ 140/90&#xD;
                    mmHg at the screening visit.&#xD;
  &#xD;
                 -  Seated pulse rate is ≥ 40 beats per minute (bpm) and ≤ 99 bpm at the screening&#xD;
                    visit.&#xD;
  &#xD;
                 -  Part 1 only: QTcF interval is ≤ 450 msec (males and females) and has ECG findings&#xD;
                    considered normal or not clinically significant by the Investigator or designee&#xD;
                    at the screening visit.&#xD;
  &#xD;
                 -  Part 2 and 3: ECG findings considered normal or not clinically significant by the&#xD;
                    Investigator or designee at the screening visit.&#xD;
  &#xD;
                 -  Estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m2 at the screening&#xD;
                    visit.&#xD;
  &#xD;
                 -  Liver function tests including Alanine aminotransferase (ALT), Aspartate&#xD;
                    aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin ≤ upper&#xD;
                    limit of normal (ULN) at the screening visit and at check-in.&#xD;
  &#xD;
                 -  No clinically significant hypokalemia or hypomagnesemia at the screening visit.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
               of the screening visit or expected during the conduct of the study.&#xD;
  &#xD;
            2. History or presence of clinically significant medical or psychiatric condition or&#xD;
               disease in the opinion of the Investigator or designee.&#xD;
  &#xD;
            3. History of any illness that, in the opinion of the Investigator or designee, might&#xD;
               confound the results of the study or poses an additional risk to the participant by&#xD;
               their participation in the study.&#xD;
  &#xD;
            4. Has a history of any of the following:&#xD;
  &#xD;
                 -  Active infection or febrile illness within 7 days prior to first dosing, as&#xD;
                    assessed by the Investigator or designee.&#xD;
  &#xD;
                 -  Symptoms suggestive of systemic or invasive infection requiring hospitalization&#xD;
                    or treatment within 8 weeks prior to first dosing.&#xD;
  &#xD;
                 -  Chronic or recurrent bacterial disease, including but not limited to chronic&#xD;
                    pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or&#xD;
                    chronic skin ulcerations/infections or fungal infections (except superficial&#xD;
                    nailbed mycosis).&#xD;
  &#xD;
                 -  An infected joint prosthesis unless that prosthesis has been removed or replaced&#xD;
                    greater than 60 days prior to first dosing.&#xD;
  &#xD;
                 -  Opportunistic infections.&#xD;
  &#xD;
                 -  Cancer or lymphoproliferative disease within 5 years prior to first dosing.&#xD;
  &#xD;
                 -  Known or suspected condition/illness that is consistent with compromised&#xD;
                    immunity, including but not limited to any identified congenital or acquired&#xD;
                    immunodeficiency; splenectomy.&#xD;
  &#xD;
                 -  Liver or other solid organ transplant.&#xD;
  &#xD;
            5. Has history or presence of alcoholism and/or drug abuse within the past 2 years prior&#xD;
               to first dosing, as determined by the Investigator or designee.&#xD;
  &#xD;
            6. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs,&#xD;
               including macrolide antibiotics (Part 1 only; eg, erythromycin) or anti-seizure agents&#xD;
               (Part 2 only; eg, phenytoin) or anti-viral drugs (Part 3 only; eg, efavirenz).&#xD;
  &#xD;
            7. Part 2 and Part 3 only: Any positive responses on the Columbia-Suicide Severity Rating&#xD;
               Scale (C-SSRS) or has a risk of suicide according to the Investigator's or designee&#xD;
               judgment based on the assessment of the C-SSRS at the screening visit or check-in or&#xD;
               has made a suicide attempt within 12 months before the first dosing.&#xD;
  &#xD;
            8. Part 2 only: History of seizure, epilepsy, severe head injury, multiple sclerosis, or&#xD;
               other known neurological conditions which the Investigator or designee considers to be&#xD;
               clinically significant.&#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>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Takeda</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Takeda Contact</last_name>
      <phone>+1-877-825-3327</phone>
      <email>medinfoUS@takeda.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Celerion - Tempe, AZ Site</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85283</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
      </contact>
      <investigator>
        <last_name>Danielle Armas</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Drug Therapy</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Efavirenz</mesh_term>
      <mesh_term>Erythromycin</mesh_term>
      <mesh_term>Erythromycin Estolate</mesh_term>
      <mesh_term>Erythromycin Ethylsuccinate</mesh_term>
      <mesh_term>Erythromycin stearate</mesh_term>
      <mesh_term>Phenytoin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995249
  org study id: TAK-279-1002
  nct id: NCT05995249
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main aim of this study is to find out how the body of a healthy adult processes TAK-279
        (pharmacokinetics) when substances that either hinder or help the human metabolism such as
        erythromycin, phenytoin and efavirenz are given along with TAK-279. Other aim is to learn
        about side effects and how well it is tolerated when TAK-279 is given alone and together with
        substances that impact human metabolism.
  
        The participants will need to stay at the clinic for up to 26 days.
  The drug being tested in this study is called TAK-279. TAK-279 is being tested to assess the
        effect of a moderate CYP3A4 inhibitor (erythromycin- Part 1), and of strong (phenytoin- Part
        2) and moderate (efavirenz- Part 3) CYP3A4 inducers on the pharmacokinetics of TAK-279 in
        healthy participants.
  
        The study will enroll approximately 48 patients. Participants will be enrolled in one of the
        three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with
        multiple doses of either erythromycin, phenytoin or efavirenz in Period 2 as given below:
  
          -  Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
  
          -  Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
  
          -  Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
  
        All participants will be monitored for up to 14 days postdose in each Part. Based on an
        evaluation of the results from Parts 1 and 2, participants will be enrolled for Part 3.
  
        This single-center trial will be conducted in the United States. The overall study duration
        is approximately 58 days for Part 1, 66 days for Part 2, and 63 days for Part 3.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279
  time frame: Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3
  measure: Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279
  time frame: Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3
  measure: Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279
  time frame: Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3
  measure: Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  time frame: From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)
  measure: Part 2 and Part 3: Number of Participants with Suicidal Ideation as per the Columbia-suicide Severity Rating Scale (C-SSRS)
  time frame: Predose and at multiple timepoints post dose from Day 1 up to Day 11 in Part 1, up to Day 19 in Part 2 and up to Day 16 in Part 3
  description: The C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation.
  measure: Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs
  time frame: From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)
  description: Abnormal vital sign assessment will include assessments of systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as determined by the investigator.
  measure: Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings
  time frame: From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)
  description: Abnormal 12-lead ECG findings will include heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position as determined by the investigator.
  measure: Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values
  time frame: From Day 1 of period 1 through Day 14 after the last dose in period 2 (up to approximately 66 days)
  description: Abnormal laboratory investigation will include hematology, chemistry, and urinalysis analysis as determined by the investigator.
  arm group label: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
  arm group type: Experimental
  description: Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study.
  arm group label: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
  arm group type: Experimental
  description: Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study.
  arm group label: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
  arm group type: Experimental
  description: Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.
  intervention type: Drug
  intervention name: TAK-279
  description: TAK-279 capsules
  arm group label: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
  arm group label: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
  arm group label: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
  intervention type: Drug
  intervention name: Erythromycin
  description: Erythromycin tablets
  arm group label: Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg
  intervention type: Drug
  intervention name: Phenytoin
  description: Phenytoin capsules
  arm group label: Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg
  intervention type: Drug
  intervention name: Efavirenz
  description: Efavirenz tablets
  arm group label: Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Study Director
  role: Study Director
  affiliation: Takeda
  last name: Takeda Contact
  phone: +1-877-825-3327
  email: medinfoUS@takeda.com
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Efavirenz
  mesh term: Erythromycin
  mesh term: Erythromycin Estolate
  mesh term: Erythromycin Ethylsuccinate
  mesh term: Erythromycin stearate
  mesh term: Phenytoin
  sharing ipd: Yes
  ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
  ipd url: https://vivli.org/ourmember/takeda/