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/NCT05994807</url>
    </required_header>
    <id_info>
      <org_study_id>DCE806103</org_study_id>
      <nct_id>NCT05994807</nct_id>
    </id_info>
    <brief_title>A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Single-Center, Open-Label, 2-Cohort, Fixed-Sequence, Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>DICE Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>DICE Therapeutics, Inc.</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 primary objective of this study is to assess the effect of a cytochrome P450 3A4 (CYP3A4)&#xD;
        inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose&#xD;
        pharmacokinetics (PK) of DC-806 coadministered with itraconazole or carbamazepine in healthy&#xD;
        male and female participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 22, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cohort 1: Maximum Observed Plasma Concentrations (Cmax) of DC-806</measure>
      <time_frame>Day 1 to Day 11</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 2: Cmax of DC-806</measure>
      <time_frame>Day 1 to Day 25</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 1: Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t) of DC-806</measure>
      <time_frame>Day 1 to Day 11</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 2: AUC0-t of DC-806</measure>
      <time_frame>Day 1 to Day 25</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 1: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of DC-806</measure>
      <time_frame>Day 1 to Day 11</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort 2: AUC0-inf of DC-806</measure>
      <time_frame>Day 1 to Day 25</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cohorts 1 and 2: Number of Participants who Experience an Adverse Event</measure>
      <time_frame>Up to a maximum of 31 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in Cohort 1 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with itraconazole after the wash-out period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in Cohort 2 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with carbamazepine after the wash-out period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DC-806</intervention_name>
      <description>Oral tablets</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itraconazole</intervention_name>
      <description>Oral capsules</description>
      <arm_group_label>Cohort 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carbamazepine</intervention_name>
      <description>Oral tablets</description>
      <arm_group_label>Cohort 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sex : male or female; females must be of non-childbearing potential, or&#xD;
               postmenopausal.&#xD;
  &#xD;
            2. Age : 18 to 55 years, inclusive, at screening.&#xD;
  &#xD;
            3. Body mass index (BMI) : 18.0 to 32.0 kg/m^2, inclusive, at screening.&#xD;
  &#xD;
            4. Weight : ≥50 kg, inclusive, at screening.&#xD;
  &#xD;
            5. Status : healthy participants. Healthy status as defined by the absence of evidence of&#xD;
               any clinically significant, in the opinion of the investigator, active, or chronic&#xD;
               disease.&#xD;
  &#xD;
            6. Male participants and female participants of childbearing potential must agree to use&#xD;
               protocol specified methods of contraception and comply with pregnancy precautions as&#xD;
               described in the protocol.&#xD;
  &#xD;
            7. All prescribed medication must have been stopped at least 14 days prior to admission&#xD;
               to the clinical site.&#xD;
  &#xD;
            8. All over-the-counter medication, vitamin preparations and other food supplements, or&#xD;
               herbal medications (e.g., St. John's wort) must have been stopped at least 7 days (or&#xD;
               5 half-lives for certain medications, whichever is longer) prior to admission to the&#xD;
               clinical site. Occasional use of acetaminophen/paracetamol (e.g., up to 2 grams per&#xD;
               day) is permitted during this period and throughout the study.&#xD;
  &#xD;
            9. Ability and willingness to abstain from alcohol-, caffeine-, and&#xD;
               methylxanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate,&#xD;
               energy drinks) from 48 hours (2 days) prior to admission to the clinical site and&#xD;
               during confinement at the clinical site.&#xD;
  &#xD;
           10. Willingness to abstain from any strenuous physical exercise from 96 hours (4 days)&#xD;
               prior to admission and during confinement at the clinical site.&#xD;
  &#xD;
           11. Good physical and mental health on the basis of medical history, physical examination,&#xD;
               clinical laboratory assessments, 12-lead electrocardiogram (ECG), Columbia-Suicide&#xD;
               Severity Rating Scale (C-SSRS) (Cohort 2 only) and vital signs, as judged by the&#xD;
               Investigator.&#xD;
  &#xD;
           12. Willing and able to sign the informed consent form (ICF).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Employee of ICON or the Sponsor.&#xD;
  &#xD;
            2. History of relevant drug and/or food allergies, in the opinion of the Investigator.&#xD;
  &#xD;
            3. Females who are currently breastfeeding.&#xD;
  &#xD;
            4. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily within 3 months prior to&#xD;
               screening.&#xD;
  &#xD;
            5. Unwilling or unable to abstain from tobacco products within the 48 hours (2 days)&#xD;
               prior to admission and during confinement at the clinical site.&#xD;
  &#xD;
            6. History of alcohol abuse or drug addiction (including soft drugs like cannabis&#xD;
               products) within 1 year prior to screening.&#xD;
  &#xD;
            7. Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines&#xD;
               [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic&#xD;
               antidepressants, and alcohol) at screening or admission to the clinical site.&#xD;
  &#xD;
            8. History within the previous 12 months of alcohol consumption exceeding 2 standard&#xD;
               drinks per day on average. Alcohol consumption will be prohibited 48 hours prior to&#xD;
               admission to the clinical facility and until discharge in the study period.&#xD;
  &#xD;
            9. Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies,&#xD;
               or human immunodeficiency virus (HIV) 1 and 2 antibodies.&#xD;
  &#xD;
           10. Consumption of any nutrients known to modulate cytochrome P450 (CYP450) enzymes&#xD;
               activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville&#xD;
               [blood] orange products) within 14 days prior to the first administration of study&#xD;
               drug and during the study (including washout period/clinic furlough until after&#xD;
               discharge in the last study period).&#xD;
  &#xD;
           11. Participation in a drug study within 30 days prior to study drug administration in the&#xD;
               current study. Participation in 4 or more other drug studies in the 12 months prior to&#xD;
               study drug administration in the current study.&#xD;
  &#xD;
           12. History of donation of more than 450 mL of blood within 60 days prior to dosing in the&#xD;
               clinical site or planned donation before 30 days has elapsed since intake of study&#xD;
               drug.&#xD;
  &#xD;
           13. Plasma or platelet donation within 7 days of dosing and through follow-up.&#xD;
  &#xD;
           14. Significant and/or acute illness within 5 days prior to study drug administration that&#xD;
               may impact safety assessments, in the opinion of the Investigator.&#xD;
  &#xD;
           15. Unsuitable veins for infusion or blood sampling as determined by the Investigator or&#xD;
               study staff.&#xD;
  &#xD;
           16. Any other condition or prior therapy that, in the Investigator's opinion, would&#xD;
               confound or interfere with the evaluation of safety, tolerability, or pharmacokinetics&#xD;
               (PK) of the study drug, interfere with study compliance, or preclude informed consent.&#xD;
  &#xD;
               Cohort 2 Only:&#xD;
  &#xD;
           17. Individuals who have Asian ancestry (including those who have one or more Asian&#xD;
               grandparents).&#xD;
  &#xD;
           18. Presence of active suicidal ideation or positive suicide behavior using the&#xD;
               &quot;Baseline/Screening&quot; version of the C-SSRS and with either of the following criteria:&#xD;
  &#xD;
                 -  History of a suicide attempt within the 5 years prior to the Screening Visit.&#xD;
                    Participants with a history of a suicide attempt more than 5 years ago should be&#xD;
                    evaluated by a mental healthcare professional (e.g., locally licensed&#xD;
                    psychiatrist, psychologist, or master's level therapist) before enrolling into&#xD;
                    the study.&#xD;
  &#xD;
                 -  Suicidal ideation in the past month prior to the Screening Visit as indicated by&#xD;
                    a positive response (&quot;Yes&quot;) to either Question 4 or 5 of the &quot;Baseline/Screening&quot;&#xD;
                    version of the C-SSRS.&#xD;
  &#xD;
           19. History of epilepsy.&#xD;
  &#xD;
           20. Leukopenia (white blood cell count &lt;lower limit of normal [LLN]), neutropenia&#xD;
               (neutrophil count &lt;LLN), or thrombocytopenia (platelet count &lt;LLN), at screening or&#xD;
               admission (Day -1).&#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>
    <location>
      <facility>
        <name>ICON Phase I Clinic</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84124</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 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>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>DC-806</keyword>
    <keyword>Drug-Drug Interaction</keyword>
    <keyword>Itraconazole</keyword>
    <keyword>Carbamazepine</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Itraconazole</mesh_term>
      <mesh_term>Carbamazepine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05994807
  org study id: DCE806103
  nct id: NCT05994807
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary objective of this study is to assess the effect of a cytochrome P450 3A4 (CYP3A4)
        inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose
        pharmacokinetics (PK) of DC-806 coadministered with itraconazole or carbamazepine in healthy
        male and female participants.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Cohort 1: Maximum Observed Plasma Concentrations (Cmax) of DC-806
  time frame: Day 1 to Day 11
  measure: Cohort 2: Cmax of DC-806
  time frame: Day 1 to Day 25
  measure: Cohort 1: Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t) of DC-806
  time frame: Day 1 to Day 11
  measure: Cohort 2: AUC0-t of DC-806
  time frame: Day 1 to Day 25
  measure: Cohort 1: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of DC-806
  time frame: Day 1 to Day 11
  measure: Cohort 2: AUC0-inf of DC-806
  time frame: Day 1 to Day 25
  measure: Cohorts 1 and 2: Number of Participants who Experience an Adverse Event
  time frame: Up to a maximum of 31 days
  arm group label: Cohort 1
  arm group type: Experimental
  description: Participants in Cohort 1 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with itraconazole after the wash-out period.
  arm group label: Cohort 2
  arm group type: Experimental
  description: Participants in Cohort 2 will receive DC-806 single dose on Day 1, and the second dose of DC-806 along with carbamazepine after the wash-out period.
  intervention type: Drug
  intervention name: DC-806
  description: Oral tablets
  arm group label: Cohort 1
  arm group label: Cohort 2
  intervention type: Drug
  intervention name: Itraconazole
  description: Oral capsules
  arm group label: Cohort 1
  intervention type: Drug
  intervention name: Carbamazepine
  description: Oral tablets
  arm group label: Cohort 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Itraconazole
  mesh term: Carbamazepine
  sharing ipd: No