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
NCT06211179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2024-09-19
Summary
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Treatment A: Mavacamten intact oral capsule
Specified dose on specified days
- DRUG
-
Treatment B: Mavacamten open capsule in suspension
Specified dose on specified days
- DRUG
-
Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-10
- Primary Completion
- 2024-06-13
- Completion
- 2024-06-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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