A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants

Study Overview
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Brief Summary
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Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects. Find out how much CK-3828136 is in the blood after a single dose and multiple doses. Determine the effect different doses of CK-3828136 on the pumping function of the heart.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3828136 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: CK-3828136
* Drug: Placebo for CK-3828136


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight > 50.0 kg. Exclusion Criteria: Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated: History of any significant illness or disorder. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed). History or presence of: additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities. Clinically significant illness within 4 weeks prior to check in. Participants with an inability to swallow tablets.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CK-3828136 for SAD Cohort<br>Subjects will be assigned to one of approximately 8 planned dose cohorts and receive single doses of CK-3828136 | Drug: CK-3828136<br>* CK-3828136<br>|
| Placebo Comparator: Placebo for SAD Cohort<br>Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo | Drug: Placebo for CK-3828136<br>* Placebo for CK-3828136<br>|
| Experimental: CK-3828136 for MAD Cohort<br>Subjects will be assigned to one of approximately 8 planned dose cohorts and receive multiple doses of CK-3828136 | Drug: CK-3828136<br>* CK-3828136<br>|
| Placebo Comparator: Placebo for MAD Cohort<br>Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo | Drug: Placebo for CK-3828136<br>* Placebo for CK-3828136<br>|
| Experimental: Food Effect<br>Healthy subjects will be administered CK-3828136 with and without food in a cross-over fashion. | Drug: CK-3828136<br>* CK-3828136<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs | To assess the safety and tolerability of CK-3828136 when administered orally as single or multiple doses to healthy participants | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary PK parameters of CK-3828136 including AUC | To characterize the PK of CK-3828136 after single and multiple oral doses in healthy participants | 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) | 
| Changes over time from baseline in echocardiographic parameters including, but not limited to, LVEF | To characterize the PD effects of single and multiple oral doses of CK-3828136 in healthy participants Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 | Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 | 
| PK parameters calculated using plasma CK-3828136 concentrations including AUC in fed and fasted state | PK parameters following single multiple doses in fed and fasted state | Time Frame for Food Effect Cohort: Days 1 to 7 (Treatment Periods 1 and 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CK-3828136, CK-136