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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05320094
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Mavacamten — DRUG
    Specified dose on specified days
  • Activated Charcoal with Sorbitol — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Apr 15, 2022
Status verified
Oct 2022
Primary completion
Sep 11, 2022
Completion
Sep 11, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mavacamten
  • Experimental: Mavacamten and activated charcoal with sorbitol - Dose A
  • Experimental: Mavacamten and activated charcoal with sorbitol - Dose B

Primary Outcome Measure

Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) [ Time Frame: Up to 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001DallasTexas75247-4989-

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By research site
Local Institution - 0001· Dallas, TX

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