Clinical trial NCT05304533: A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: MYK-224
Itraconazole
Verapamil
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 36 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 36 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 36 days
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 36 days
measure: Apparent terminal plasma half-life (T-HALF)
timeFrame: Up to 36 days
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to 36 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 52 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 52 days
measure: Number of participants with adverse events leading to discontinuation
timeFrame: Up to 52 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 52 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 52 days
measure: Measurement of left ventricular ejection fraction (LVEF)
timeFrame: Up to 52 days
measure: Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
timeFrame: Up to 52 days
measure: Measurement of left ventricular fractional shortening (LVFS)
timeFrame: Up to 52 days
measure: Measurement of left ventricular global longitudinal strain (LV GLS)
timeFrame: Up to 52 days
measure: Measurement of left ventricle stroke volume (LVSV)
timeFrame: Up to 52 days
measure: Number of participants with physical exam abnormalities
timeFrame: Up to 52 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 52 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Local Institution - 0001
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: