A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.

Official Title
-----------------
An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: MYK-224
* Drug: Itraconazole
* Drug: Verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index between 18 and 30 kg/m^2, inclusive Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing Exclusion Criteria: Any acute or chronic medical illness History of dizziness and/or recurrent headaches History of heart disease Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: MYK-224<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;|
| Experimental: Arm 2: MYK-224 + Itraconazole<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Drug: Itraconazole<br>* Specified dose on specified days<br>|
| Experimental: Arm 3: MYK-224 + Verapamil<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Drug: Verapamil<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 36 days | 
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) |  | Up to 36 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) |  | Up to 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) |  | Up to 36 days | 
| Apparent terminal plasma half-life (T-HALF) |  | Up to 36 days | 
| Apparent total body clearance (CLT/F) |  | Up to 36 days | 
| Number of participants with adverse events (AEs) |  | Up to 52 days | 
| Number of participants with serious adverse events (SAEs) |  | Up to 52 days | 
| Number of participants with adverse events leading to discontinuation |  | Up to 52 days | 
| Number of participants with vital sign abnormalities |  | Up to 52 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 52 days | 
| Measurement of left ventricular ejection fraction (LVEF) |  | Up to 52 days | 
| Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) |  | Up to 52 days | 
| Measurement of left ventricular fractional shortening (LVFS) |  | Up to 52 days | 
| Measurement of left ventricular global longitudinal strain (LV GLS) |  | Up to 52 days | 
| Measurement of left ventricle stroke volume (LVSV) |  | Up to 52 days | 
| Number of participants with physical exam abnormalities |  | Up to 52 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 52 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MYK-224, Itraconazole, Verapamil