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

Bristol-Myers Squibb (BMS) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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