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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: MYK-224; Drug: Itraconazole; Drug: Verapamil

• Registration Number: NCT05304533
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2022-04-21
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: MYK-224 + Verapamil	MYK-224	-
Arm 2: MYK-224 + Itraconazole	Itraconazole	-
Arm 3: MYK-224 + Verapamil	Verapamil	-
Arm 2: MYK-224 + Itraconazole	MYK-224	-
Arm 1: MYK-224	MYK-224	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Dallas, Texas, United States