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Completed

NCT Number: NCT05924815

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc 2420

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.
  • Continuous non-smoker who has not used nicotine- and tobacco -containing products for at least 3 months prior to the first dosing based on participant self- reporting.
  • Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at the screening visit.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the PI or designee, including the following:
  • Supine blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit.
  • Oxygen saturation (SpO2) is ≥ 95% at the screening visit.
  • Liver function tests (e.g., bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) considered not clinically significant in the opinion of the PI or designee at the screening visit.
  • Estimated creatinine clearance ≥ 90 mL/min at the screening visit.
  • No clinically significant history and presence of ECG findings as judged by the PI or designee at the screening visit and first check-in, including each of the following:
  • HR between 50 bpm and 100 bpm, inclusive.
  • QTcF interval is ≤450 msec (males) and ≤460 msec (females).
  • QRS ≤110 msec; if >110 msec, result will be confirmed by a manual over read.
  • PR ≤220 msec.
  • LVEF ≥65% at the screening visit.

Exclusion criteria

  • History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.

Treatment and study plan

Aficamten

Drug

Oral Tablet

Aficamten-matching Placebo

Drug

Oral Tablet

moxifloxacin

Drug

Oral Tablet

Primary outcomes

  1. Part A: To determine the dose for Part B

    Time frame: Baseline to End of Study, up to 8 weeks

    To determine the dose for Part B based on Part A PK and safety data.

  2. Part B: placebo-corrected dQTcF for aficamten

    Time frame: Baseline to End of Study, up to 14.5 weeks

    To evaluate the effect of a single oral dose of aficamten on the QTc interval in healthy participants.

Secondary outcomes

  1. Part B: placebo-corrected dQTcF for moxifloxacin

    Time frame: Baseline to End of Study, up to 14.5 weeks

    To demonstrate assay sensitivity of the study to detect a small QTc effect using moxifloxacin as a positive control in healthy participants.

Sponsors and collaborators

Lead sponsor

Cytokinetics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2023
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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