A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Part of paid clinical trials in Anaheim, California.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT05658146
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Participants
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Mavacamten Capsule 1 — DRUGSpecified dose on specified days
- Mavacamten Capsule 2 — DRUGSpecified dose on specified days
- Mavacamten Capsule 3 — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Key Dates
- Start date
- Jan 6, 2023
- Status verified
- Oct 2023
- Primary completion
- Jul 5, 2023
- Completion
- Jul 5, 2023
Study Design
- Enrollment
- 95 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Sequence 1
- Experimental: Sequence 2
- Experimental: Sequence 3
- Experimental: Sequence 4
- Experimental: Sequence 5
- Experimental: Sequence 6
Primary Outcome Measure
Maximum Observed Serum Concentration (Cmax) [ Time Frame: From Day 1 up to Day 35±2 of each period ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0001 | Anaheim | California | 92801 | - |
| Local Institution - 0002 | Miami | Florida | 33126 | - |
| Local Institution - 0003 | Springfield | Missouri | 65802 | - |
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