Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Cytokinetics
Study ID
NCT05924815
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.

Key Dates

Start date
May 15, 2023
Status verified
Dec 2023
Primary completion
Nov 14, 2023
Completion
Nov 14, 2023

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A (Dose Finding Cohort 1): Aficamten 50 mg
    Participants in this arm will receive a single oral dose of 50 mg aficamten.
  • Experimental: Part A (Dose Finding Cohort 2): Aficamten 75 mg
    Participants in this arm will receive a single oral dose up to 75 mg aficamten.
  • Experimental: Part A (Dose Finding Cohort 3): Aficamten 100 mg
    Participants in this arm will receive a single oral dose up to 100 mg aficamten.
  • Experimental: Part B (TQT Study): Aficamten
    Participants will receive a single oral dose of aficamten. The dose will be determined based on review of Part A PK parameters, echocardiogram parameters, safety, and tolerability for aficamten.
  • Placebo Comparator: Part B (TQT Study): Aficamten-matching Placebo
    Participants in this arm will receive a single oral dose of aficamten-matching placebo.
  • Active Comparator: Part B (TQT Study): Moxifloxacin 400 mg
    Participants will receive a single oral dose of 400 mg moxifloxacin

Primary Outcome Measure

Part A: To determine the dose for Part B [ Time Frame: Baseline to End of Study, up to 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc 2420TempeArizona85283-

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Celerion, Inc 2420· Tempe, AZ

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