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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Mavacamten; Drug: Activated Charcoal with Sorbitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05320094

CV027-043

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 3 patient groups

Mavacamten

Experimental group

Treatment:

Drug: Mavacamten

Mavacamten and activated charcoal with sorbitol - Dose A

Experimental group

Treatment:

Drug: Mavacamten

Drug: Activated Charcoal with Sorbitol

Mavacamten and activated charcoal with sorbitol - Dose B

Experimental group

Treatment:

Drug: Mavacamten

Drug: Activated Charcoal with Sorbitol