Status:
COMPLETED
A Study to Evaluate the Effects on the Single-Dose Drug Levels 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 on the single-dose drug levels of mavacamten in healthy participants.
Eligibility Criteria
Inclusion
- Body mass index between 18 and 32 kg/m\^2, inclusive, at the Screening Visit
- Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1
Exclusion
- Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2022
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05362045
Start Date
May 16 2022
End Date
August 19 2022
Last Update
November 21 2022
Active Locations (4)
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1
Clinical pharmacology of Miami
Miami, Florida, United States, 33014
2
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
3
QPS Springfield
Springfield, Missouri, United States, 65802
4
Ppd Phase I Clinic
Austin, Texas, United States, 78744