Trials / Completed
CompletedNCT05824143
Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants
A Phase 1, Open-label, Fixed-Sequence Trial to Evaluate the Effect of Carbamazepine on the Single-Dose Pharmacokinetics of Darigabat in Healthy Adult Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Cerevel Therapeutics, LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of the study is to evaluate the effect of increased metabolizing enzyme (cytochrome P450 \[CYP\] 3A4) due to carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of darigabat in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Darigabat | Oral tablet |
| DRUG | Carbamazepine | Oral tablets |
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2023-07-07
- Completion
- 2023-07-07
- First posted
- 2023-04-21
- Last updated
- 2023-08-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05824143. Inclusion in this directory is not an endorsement.