A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2022-07-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Charcoal; Sorbitol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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