A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5 mg Mavacamten in Healthy Participants
Part of paid clinical trials in San Antonio, Texas.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06211179
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Treatment A: Mavacamten intact oral capsule — DRUGSpecified dose on specified days
- Treatment B: Mavacamten open capsule in suspension — DRUGSpecified dose on specified days
- Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) — DRUGSpecified dose on specified days
Study Details
The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
Key Dates
- Start date
- Jan 10, 2024
- Status verified
- Sep 2024
- Primary completion
- Jun 13, 2024
- Completion
- Jun 13, 2024
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Sequence ABC
- Experimental: Sequence BCA
- Experimental: Sequence CAB
Primary Outcome Measure
Maximum observed concentration (Cmax) [ Time Frame: Up to 37 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0001 | San Antonio | Texas | 78217 | - |
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