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

Part of paid clinical trials in Anaheim, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05658146
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Jan 6, 2023
Status verified
Oct 2023
Primary completion
Jul 5, 2023
Completion
Jul 5, 2023

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1
  • Experimental: Sequence 2
  • Experimental: Sequence 3
  • Experimental: Sequence 4
  • Experimental: Sequence 5
  • Experimental: Sequence 6

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: From Day 1 up to Day 35±2 of each period ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 0001AnaheimCalifornia92801-
Local Institution - 0002MiamiFlorida33126-
Local Institution - 0003SpringfieldMissouri65802-

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