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

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study, up to 14.5 weeks

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

Side effects data

From 2023 Phase 2 trial • 10 Patients • NCT04039204

40%

Abnormal uterine bleeding

100%

80%

60%

40%

20%

Study treatment Arm

Oral Contraceptives (Ortho Cyclen)

Elagolix

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