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CK-4021586 Safety Study in Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male and female participants aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight > 50.0 kg
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2)
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a new drug in healthy people. It will explore how much of the drug is in the blood and its effects on heart function.

Who is the study for?
Healthy adults aged 18-55 with a BMI of 18.0-30.0 kg/m2 and weight over 50 kg can join this trial. They shouldn't have any major health issues, allergies to drugs, or history of substance abuse in the last two years. Participants must not have had certain stomach surgeries that affect drug absorption.Check my eligibility
What is being tested?
The study is testing CK-4021586's safety after one dose and repeated doses in healthy people. It will also check how much of the drug gets into the blood, its effects on heart function, and if food affects its levels after a single dose.See study design
What are the potential side effects?
Possible side effects are not detailed but monitoring for general safety and tolerability suggests potential for typical drug-related reactions such as headaches, nausea, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-55 years old, with a BMI of 18-30 and weigh more than 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame for sad cohorts: day -1 - day 7; time frame for mad cohorts: day -1 - day 14; time frame for food effect cohorts: days 1 to 7 (treatment periods 1 and 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of AEs
Secondary outcome measures
Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF
Primary PK parameters of CK-4021586 including AUC

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Food EffectExperimental Treatment1 Intervention
Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion
Group II: CK-4021586 for SAD CohortExperimental Treatment1 Intervention
Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586
Group III: CK-4021586 for MAD CohortExperimental Treatment1 Intervention
Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586
Group IV: Placebo for SAD CohortPlacebo Group1 Intervention
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
Group V: Placebo for MAD CohortPlacebo Group1 Intervention
Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo

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
15,176 Total Patients Enrolled
Scientific Leadership at CytokineticsStudy DirectorCytokinetics

Media Library

CK-4021586 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05877053 — Phase 1
Healthy Subjects Research Study Groups: CK-4021586 for SAD Cohort, Placebo for SAD Cohort, Food Effect, CK-4021586 for MAD Cohort, Placebo for MAD Cohort
Healthy Subjects Clinical Trial 2023: CK-4021586 Highlights & Side Effects. Trial Name: NCT05877053 — Phase 1
CK-4021586 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05877053 — Phase 1

Frequently Asked Questions

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

What criteria must be met for someone to participate in this clinical research?

"Candidates that aspire to join this medical experiment must be of a sound build and between the ages of 18-55. The overall number of participants is planned at 132 individuals."

Answered by AI

Is the age cap of this clinical trial at 80 years or higher?

"The age range for this trial is between 18 and 55. Patients below the legal age of consent are covered by 58 studies, whereas 381 trials target those older than 65 years old."

Answered by AI

Is CK-4021586 an acceptable treatment for those suffering from Seasonal Affective Disorder?

"Due to the preliminary nature of this trial, CK-4021586's safety index was rated a 1. This is an indication that there is not much data supporting either its efficacy or security as a treatment for SAD Cohort."

Answered by AI

Are there any vacancies remaining for those wishing to participate in this clinical trial?

"Affirmative. Clinicaltrials.gov hosts evidence that this clinical trial is actively recruiting participants, first announced on May 9th 2023 and last updated on the 17th of the same month."

Answered by AI

How many participants are included in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical investigation is presently recruiting participants after being initially posted on May 9th 2023 and lastly edited on 17th of the same month. The experiment needs 132 patients from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
2023. "A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05877053.
~69 spots leftby Apr 2025
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