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

Part of paid clinical trials in Miami, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05362045
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

Study Details

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

Key Dates

Start date
May 16, 2022
Status verified
Nov 2022
Primary completion
Aug 19, 2022
Completion
Aug 19, 2022

Study Design

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

Arms

  • Experimental: Mavacamten- Dose A
  • Experimental: Mavacamten- Dose B

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 1 month ]

Locations (4)

FacilityCityStateZIPSite coordinators
Advanced Pharma CR, LLCMiamiFlorida33147-
Clinical pharmacology of MiamiMiamiFlorida33014-
QPS SpringfieldSpringfieldMissouri65802-
Ppd Phase I ClinicAustinTexas78744-

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