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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Mavacamten

Study type: Interventional

Funder types: Industry

Identifiers

NCT05362045

CV027-070

Details and patient eligibility

About

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

Enrollment: 158 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

Mavacamten- Dose A

Experimental group

Treatment:

Drug: Mavacamten

Mavacamten- Dose B

Experimental group

Treatment:

Drug: Mavacamten