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

NCT ID: NCT05924815

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2023-11-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A (Dose Finding Cohort 1): Aficamten 50 mg

Participants in this arm will receive a single oral dose of 50 mg aficamten.

Group Type: EXPERIMENTAL

Aficamten

Intervention Type: DRUG

Oral Tablet

Part A (Dose Finding Cohort 2): Aficamten 75 mg

Participants in this arm will receive a single oral dose up to 75 mg aficamten.

Group Type: EXPERIMENTAL

Aficamten

Intervention Type: DRUG

Oral Tablet

Part A (Dose Finding Cohort 3): Aficamten 100 mg

Participants in this arm will receive a single oral dose up to 100 mg aficamten.

Group Type: EXPERIMENTAL

Aficamten

Intervention Type: DRUG

Oral Tablet

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.

Group Type: EXPERIMENTAL

Aficamten

Intervention Type: DRUG

Oral Tablet

Part B (TQT Study): Aficamten-matching Placebo

Participants in this arm will receive a single oral dose of aficamten-matching placebo.

Group Type: PLACEBO_COMPARATOR

Aficamten-matching Placebo

Intervention Type: DRUG

Oral Tablet

Part B (TQT Study): Moxifloxacin 400 mg

Participants will receive a single oral dose of 400 mg moxifloxacin

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

Oral Tablet

Interventions

Aficamten

Oral Tablet

Intervention Type: DRUG

Aficamten-matching Placebo

Oral Tablet

Intervention Type: DRUG

Moxifloxacin

Oral Tablet

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cytokinetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cytokinetics, MD

Role: STUDY_DIRECTOR

Cytokinetics

Locations

Celerion, Inc 2420

Tempe, Arizona, United States

Countries

United States

Other Identifiers

CY 6019

Identifier Type: -

Identifier Source: org_study_id