Trials / Completed
CompletedNCT05658146
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mavacamten Capsule 1 | Specified dose on specified days |
| DRUG | Mavacamten Capsule 2 | Specified dose on specified days |
| DRUG | Mavacamten Capsule 3 | Specified dose on specified days |
Timeline
- Start date
- 2023-01-06
- Primary completion
- 2023-07-05
- Completion
- 2023-07-05
- First posted
- 2022-12-20
- Last updated
- 2023-10-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05658146. Inclusion in this directory is not an endorsement.