A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.

Key facts

Study ID

NCT05362045

Run by

Bristol-Myers Squibb

People needed

158

Starts

2022-05-16

Expected to finish

2022-08-19

Last updated by the study team

2022-11-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical pharmacology of Miami — Miami, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• QPS Springfield — Springfield, Missouri, United States
• Ppd Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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