Trials / Completed
CompletedNCT05712265
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
A Phase 1, Open-Label, Fixed-Sequence Crossover Study to Evaluate the Effect of a Strong Inhibitor of Cytochrome P450 2C19 on the Pharmacokinetics of Miricorilant in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Corcept Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 \[(CYP) 2C19\] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Miricorilant | Miricorilant 6 x 100 mg coated tablets |
| DRUG | Fluvoxamine | Fluvoxamine 50 mg tablet |
Timeline
- Start date
- 2023-01-24
- Primary completion
- 2023-02-23
- Completion
- 2023-02-23
- First posted
- 2023-02-03
- Last updated
- 2023-03-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05712265. Inclusion in this directory is not an endorsement.