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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 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. |
|
| Cohort 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-806 | Drug | Oral tablets |
| |
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Maximum Observed Plasma Concentrations (Cmax) of DC-806 | Day 1 to Day 11 | |
| Cohort 2: Cmax of DC-806 | Day 1 to Day 25 | |
| Cohort 1: Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t) of DC-806 | Day 1 to Day 11 | |
| Cohort 2: AUC0-t of DC-806 | Day 1 to Day 25 | |
| Cohort 1: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of DC-806 | Day 1 to Day 11 | |
| Cohort 2: AUC0-inf of DC-806 | Day 1 to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Number of Participants who Experience an Adverse Event | Up to a maximum of 31 days |
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Inclusion Criteria:
Exclusion Criteria:
Employee of ICON or the Sponsor.
History of relevant drug and/or food allergies, in the opinion of the Investigator.
Females who are currently breastfeeding.
Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily within 3 months prior to screening.
Unwilling or unable to abstain from tobacco products within the 48 hours (2 days) prior to admission and during confinement at the clinical site.
History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 1 year prior to screening.
Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or admission to the clinical site.
History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average. Alcohol consumption will be prohibited 48 hours prior to admission to the clinical facility and until discharge in the study period.
Positive screen for hepatitis B surface antigen, hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies.
Consumption of any nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to the first administration of study drug and during the study (including washout period/clinic furlough until after discharge in the last study period).
Participation in a drug study within 30 days prior to study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to study drug administration in the current study.
History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical site or planned donation before 30 days has elapsed since intake of study drug.
Plasma or platelet donation within 7 days of dosing and through follow-up.
Significant and/or acute illness within 5 days prior to study drug administration that may impact safety assessments, in the opinion of the Investigator.
Unsuitable veins for infusion or blood sampling as determined by the Investigator or study staff.
Any other condition or prior therapy that, in the Investigator's opinion, would confound or interfere with the evaluation of safety, tolerability, or pharmacokinetics (PK) of the study drug, interfere with study compliance, or preclude informed consent.
Cohort 2 Only:
Individuals who have Asian ancestry (including those who have one or more Asian grandparents).
Presence of active suicidal ideation or positive suicide behavior using the "Baseline/Screening" version of the C-SSRS and with either of the following criteria:
History of epilepsy.
Leukopenia (white blood cell count \
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Phase I Clinic | Salt Lake City | Utah | 84124 | United States |
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| Drug |
Oral capsules |
|
| Carbamazepine | Drug | Oral tablets |
|
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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