Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Participants must have a body mass index between 18 and 32 kg/m2.
- Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Exclusion
- Participants must not have any significant acute or chronic medical illness.
- Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
- Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06211179
Start Date
January 10 2024
End Date
June 13 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0001
San Antonio, Texas, United States, 78217