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

Bristol-Myers Squibb45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

MYK-224DRUG

Specified dose on specified days

ItraconazoleDRUG

Specified dose on specified days

VerapamilDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution - 0001

Dallas, Texas, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax)

Time frame: 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])

Time frame: Up to 36 days

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

Time frame: Up to 36 days

Secondary Outcomes

Time of maximum observed plasma concentration (Tmax)

Time frame: Up to 36 days

Apparent terminal plasma half-life (T-HALF)

Time frame: Up to 36 days

Apparent total body clearance (CLT/F)

Time frame: Up to 36 days

Number of participants with adverse events (AEs)

Time frame: Up to 52 days

Number of participants with serious adverse events (SAEs)

Time frame: Up to 52 days

Number of participants with adverse events leading to discontinuation

Time frame: Up to 52 days

Number of participants with vital sign abnormalities

Time frame: Up to 52 days

Number of participants with electrocardiogram (ECG) abnormalities

Time frame: Up to 52 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.