A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Danicamtiv
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit. Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese). Caucasian participants must be of European or Latin American Caucasian descent. A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol. Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception. Exclusion Criteria: Any acute or chronic medical illness. Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator. History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. Note: Other protocol-defined inclusion/exclusion criteria apply.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese Cohort - Dose 1<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>* Other names: MYK-491;Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Japanese Cohort - Dose 2<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>* Other names: MYK-491;Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Japanese Cohort - Dose 3<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>* Other names: MYK-491;Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Caucasian Cohort - Dose 3<br> | Drug: Danicamtiv<br>* Specified dose on specified days<br>* Other names: MYK-491;Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Day 1 up to Day 28 | 
| Number of Participants with Vital Sign Abnormalities |  | Day 1 up to Day 7 | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities |  | Day 1 up to Day 7 | 
| Number of Participants with Physical Examination Abnormalities |  | Day 1 up to Day 7 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Day 1 up to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing | 
| Time of Maximum Observed Plasma Concentration (Tmax) |  | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing | 
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] |  | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Danicamtiv, Japanese, Caucasian