A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

Study Overview
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Brief Summary
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The purposes of this study are to: Learn about the safety and tolerability of CK 4021586 after a single dose and multiple doses in healthy subjects. Find out how much CK-4021586 is in the blood after a single dose and multiple doses. Determine the effect different doses of CK-4021586 on the pumping function of the heart. Determine the effect of food in the stomach on how much CK-4021586 is in the blood after a single dose.

Official Title
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A Phase 1, Double-blind, Randomized, Placebo-controlled, Multi-part, Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: CK-4021586
* Drug: Placebo for CK-4021586


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Significant history or clinical manifestation of any significant metabolic, allergic/immunologic, dermatologic, hepatic, renal, hematologic, respiratory, cardiovascular (including arrhythmia), gastrointestinal, gallbladder/biliary, musculoskeletal, neurologic, or psychiatric disorder in the opinion of the Investigator or designee. History of significant hypersensitivity or allergy to any drug compound or other substance, unless approved by the Investigator and the Sponsor's Medical Monitor. 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). Participants with breast implants that may impede echocardiography Clinically significant illness within 4 weeks prior to check in. Significant ECG abnormalities (heart block, prolonged QT interval, arrhythmia) History of, or current substance abuse (drug or alcohol), known drug or alcohol dependence within the last 2 years prior to Screening, or positive test for drugs of abuse during the screening period Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study, in the judgment of the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CK-4021586 for SAD Cohort<br>Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 | Drug: CK-4021586<br>* CK-4021586<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-4021586<br>* Placebo for CK-4021586<br>|
| Experimental: CK-4021586 for MAD Cohort<br>Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 | Drug: CK-4021586<br>* CK-4021586<br>|
| Placebo Comparator: Placebo for MAD Cohort<br>Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo | Drug: Placebo for CK-4021586<br>* Placebo for CK-4021586<br>|
| Experimental: Food Effect<br>Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion | Drug: CK-4021586<br>* CK-4021586<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-4021586 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-4021586 including AUC | To characterize the PK of CK-4021586 and CK-4022235 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-4021586 in healthy participants | Time Frame for SAD Cohorts: Day -1 - Day 7; Time Frame for MAD Cohorts: Day -1 - Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CK-586, CK-4021586