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Unknown

CK-3828136 for 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
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 will assess the safety and effectiveness of CK-3828136 in healthy people over multiple doses. It will measure how much is in the blood and its effect on the heart.

Who is the study for?
Healthy adults aged 18-45 with a BMI of 18.0-30.0 kg/m2 and weight over 50 kg can join this trial. It's not for those with significant illnesses, heart issues like prolonged QTcF interval or arrhythmias, history of stomach/intestinal surgery affecting drug absorption, recent sickness, or trouble swallowing tablets.Check my eligibility
What is being tested?
The study tests the safety and tolerability of CK-3828136 in healthy people after one dose and repeated doses. It also measures how much of the drug is present in the blood over time and its impact on heart function.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, nausea, headache, fatigue or allergic responses to components of CK-3828136.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame for food effect cohort: days 1 to 7 (treatment periods 1 and 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame for food effect cohort: 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
PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state
Primary PK parameters of CK-3828136 including AUC

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Food EffectExperimental Treatment1 Intervention
Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion.
Group II: CK-3828136 for SAD CohortExperimental Treatment1 Intervention
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136
Group III: CK-3828136 for MAD CohortExperimental Treatment1 Intervention
Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136
Group IV: Placebo for MAD CohortPlacebo Group1 Intervention
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo
Group V: Placebo for SAD CohortPlacebo Group1 Intervention
Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses 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
15,230 Total Patients Enrolled
Cytokinetics, MDStudy DirectorCytokinetics
5 Previous Clinical Trials
1,502 Total Patients Enrolled

Media Library

CK-3828136 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05662215 — Phase 1
Healthy Subjects Research Study Groups: Food Effect, Placebo for MAD Cohort, Placebo for SAD Cohort, CK-3828136 for SAD Cohort, CK-3828136 for MAD Cohort
Healthy Subjects Clinical Trial 2023: CK-3828136 Highlights & Side Effects. Trial Name: NCT05662215 — Phase 1
CK-3828136 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662215 — Phase 1

Frequently Asked Questions

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

For which demographic is this medical research best suited?

"This clinical trial is recruiting 78 healthy subjects (hs), aged 18 to 45, as participants."

Answered by AI

To what extent can CK-3828136 alleviate the symptoms of SAD Cohort?

"Due to its Phase 1 status, CK-3828136 for SAD Cohort's safety rating is a modest 1 on our scale of assessment. This reflects the miniscule amount of data that currently supports both efficacy and safety."

Answered by AI

How many participants are being treated through this clinical experiment?

"Affirmative. The clinicaltrial.gov database confirms that this medical study, which was first posted on December 1st 2022, is actively searching for patients to enroll in the trial. 78 individuals are needed from one location."

Answered by AI

Does this medical trial allow for applicants who are older than 35 years of age?

"Eligible participants for this trial must be of an age between 18 and 45 years old. Separately, there are 51 studies specifically created to accommodate patients younger than 18 while 370 trials have been developed with elderly applicants in mind."

Answered by AI

Are there any open slots for participation in this experiment?

"The data on clinicaltrials.gov confirms that the enrollment for this medical trial is open to participants. The study was first published on December 1st, 2022 and has been updated as recently as December 20th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Labcorp Clinical Research Unit Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants
2022. "A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662215.
~33 spots leftby Apr 2025
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