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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: MYK-224; Drug: Verapamil; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05304533

CV029-005

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Arm 1: MYK-224

Experimental group

Treatment:

Drug: MYK-224

Arm 2: MYK-224 + Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: MYK-224

Arm 3: MYK-224 + Verapamil

Experimental group

Treatment:

Drug: Verapamil

Drug: MYK-224