Status:
COMPLETED
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
Eligibility Criteria
Inclusion
- Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
Exclusion
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05320094
Start Date
April 15 2022
End Date
September 11 2022
Last Update
November 8 2022
Active Locations (1)
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1
Local Institution - 0001
Dallas, Texas, United States, 75247-4989