A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.

Official Title
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A Phase 1, Open-label, Randomized, Single-dose, 3-Period, 3-Sequence Crossover Study to Assess the Relative Bioavailability of the Intended Commercial Formulation Versus the Previous MyoKardia Formulation of Danicamtiv and to Assess the Effect of Food on the Pharmacokinetics of the Intended Commercial Formulation in Healthy Adult Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Danicamtiv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive Participants with resting heart rate ≥ 55 bpm Seasonal allergies that do not require medication at the time of the study are acceptable Exclusion Criteria: Any acute or chronic medical illness Head injury, intracranial tumor, or aneurysm within 2 years prior to screening History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Danicamtiv<br>* Specified dose on specified days.<br>* Other names: MYK-491;|
| Experimental: Treatment B<br> | Drug: Danicamtiv<br>* Specified dose on specified days.<br>* Other names: MYK-491;|
| Experimental: Treatment C<br> | Drug: Danicamtiv<br>* Specified dose on specified days.<br>* Other names: MYK-491;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to day 16 | 
| Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF)) |  | Up to day 16 | 
| Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) |  | Up to day 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) |  | Up to day 16 | 
| Terminal elimination half-life (T-HALF) |  | Up to day 16 | 
| Apparent total body clearance (CLT/F) |  | Up to day 16 | 
| Apparent volume of distribution (Vz/F) |  | Up to day 16 | 
| Number of participants with Adverse Events (AEs) |  | Up to day 43 | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to day 43 | 
| Number of participants with vital sign abnormalities |  | Up to day 16 | 
| Number of participants with Electrocardiogram (ECG) abnormalities |  | Up to day 16 | 
| Number of participants with Physical Examination (PE) abnormalities |  | Up to day 16 | 
| Number of participants with clinical laboratory abnormalities |  | Up to day 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986434, Healthy, Biological Availability, Food Effect, MYK-491