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

Phase 1
Waitlist Available
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study, up to 14.5 weeks
Awards & highlights

Summary

This trial tests aficamten, a drug, to see how it affects the heart's electrical activity. Healthy participants are used to get clear results without other health issues interfering. The study checks if aficamten changes the heart's rhythm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study, up to 14.5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study, up to 14.5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: To determine the dose for Part B
Part B: placebo-corrected dQTcF for aficamten
Secondary study objectives
Part B: placebo-corrected dQTcF for moxifloxacin

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part B (TQT Study): AficamtenExperimental Treatment1 Intervention
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 II: Part A (Dose Finding Cohort 3): Aficamten 100 mgExperimental Treatment1 Intervention
Participants in this arm will receive a single oral dose up to 100 mg aficamten.
Group III: Part A (Dose Finding Cohort 2): Aficamten 75 mgExperimental Treatment1 Intervention
Participants in this arm will receive a single oral dose up to 75 mg aficamten.
Group IV: Part A (Dose Finding Cohort 1): Aficamten 50 mgExperimental Treatment1 Intervention
Participants in this arm will receive a single oral dose of 50 mg aficamten.
Group V: Part B (TQT Study): Moxifloxacin 400 mgActive Control1 Intervention
Participants will receive a single oral dose of 400 mg moxifloxacin
Group VI: Part B (TQT Study): Aficamten-matching PlaceboPlacebo Group1 Intervention
Participants in this arm will receive a single oral dose of aficamten-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aficamten
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CytokineticsLead Sponsor
41 Previous Clinical Trials
15,603 Total Patients Enrolled
Cytokinetics, MDStudy DirectorCytokinetics
5 Previous Clinical Trials
1,836 Total Patients Enrolled

Media Library

Part A (Dose Finding Cohort 1): Aficamten 50 mg Clinical Trial Eligibility Overview. Trial Name: NCT05924815 — Phase 1
Healthy Subjects Research Study Groups: Part A (Dose Finding Cohort 1): Aficamten 50 mg, Part A (Dose Finding Cohort 2): Aficamten 75 mg, Part A (Dose Finding Cohort 3): Aficamten 100 mg, Part B (TQT Study): Aficamten, Part B (TQT Study): Aficamten-matching Placebo, Part B (TQT Study): Moxifloxacin 400 mg
Healthy Subjects Clinical Trial 2023: Part A (Dose Finding Cohort 1): Aficamten 50 mg Highlights & Side Effects. Trial Name: NCT05924815 — Phase 1
Part A (Dose Finding Cohort 1): Aficamten 50 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924815 — Phase 1
~19 spots leftby Sep 2025
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