Local Institution - 0001
Dallas, Texas, 75247, United States
Completed
NCT Number: NCT05304533
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
MYK-224
DrugSpecified dose on specified days
Other names: BMS-986435
Itraconazole
DrugSpecified dose on specified days
Verapamil
DrugSpecified dose on specified days
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
-
Measurement of left ventricular ejection fraction (LVEF)
Time frame: Up to 52 days
-
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Time frame: Up to 52 days
-
Measurement of left ventricular fractional shortening (LVFS)
Time frame: Up to 52 days
-
Measurement of left ventricular global longitudinal strain (LV GLS)
Time frame: Up to 52 days
-
Measurement of left ventricle stroke volume (LVSV)
Time frame: Up to 52 days
-
Number of participants with physical exam abnormalities
Time frame: Up to 52 days
-
Number of participants with clinical laboratory abnormalities
Time frame: Up to 52 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Mar 31, 2022
- Registry last updated
- Jan 13, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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