NCT05924815

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

A Randomized, 2-Part, Single-Dose, Crossover Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Aficamten	Oral Tablet
DRUG	Aficamten-matching Placebo	Oral Tablet
DRUG	Moxifloxacin	Oral Tablet

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2023-06-29
• Last updated: 2023-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study