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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

Study Summary

This trial is testing a new drug to measure how it affects the heart's electrical activity.

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

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

Side effects data

From 2012 Phase 1 trial • 328 Patients • NCT01999114
53%
Infrequent bowel movements
45%
Nausea
42%
Headache
27%
Dizziness
24%
Vomiting
18%
Application site pruritus
15%
Application site irritation
14%
Abdominal discomfort
12%
Decreased appetite
11%
Somnolence
9%
Application site erythema
9%
Application site papules
8%
Fatigue
8%
Haematochezia
8%
Feeling hot
8%
Pruritus
8%
Hiccups
6%
Feeling drunk
6%
Diarrhoea
6%
Application site pustules
6%
Oropharyngeal pain
6%
Abdominal pain
6%
Dysuria
5%
Application site pain
3%
Flatulence
3%
Application site rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
BTDS
BTDS With Naltrexone
Naltrexone
Moxifloxacin
Placebo

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
40 Previous Clinical Trials
15,264 Total Patients Enrolled
Cytokinetics, MDStudy DirectorCytokinetics
5 Previous Clinical Trials
1,536 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have any eligibility requirements for participants?

"To qualify for this research, participants must be healthy and between the ages of 18-45. At present, 62 subjects are being sought out to participate in the trial."

Answered by AI

Are additional participants needed for this experiment?

"This clinical trial is still recruiting, as per the information on clinicaltrials.gov; its inaugural post was made on May 15th 2023 and it has since been revised for accuracy on June 27th of this same year."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned Aficamten 50 mg in Part A (Dose Finding Cohort 1)?

"Considering the absence of clinical evidence in support of safety and efficacy, our institution has assigned Part A (Dose Finding Cohort 1): Aficamten 50 mg a score of 1 on its risk-assessment scale."

Answered by AI

Could persons below the age of fifty partake in this clinical experiment?

"This trial has age restrictions, with only those between 18 and 45 allowed to join. Alternatively, there are 56 trials that accept younger participants and 372 studies for individuals over the age of 65."

Answered by AI

How many subjects are being monitored for this research project?

"Affirmative. The clinicaltrials.gov database indicates that the trial, which was first posted online on May 15th 2023, is currently recruiting for 62 individuals across a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
2023. "Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05924815.
~23 spots leftby Apr 2025
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