Healthy Participants Clinical Trial
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
| Verified date | January 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | November 29, 2022 |
| Est. primary completion date | November 14, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 36 days | ||
| Primary | 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 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 36 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 36 days | ||
| Secondary | Apparent terminal plasma half-life (T-HALF) | Up to 36 days | ||
| Secondary | Apparent total body clearance (CLT/F) | Up to 36 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 52 days | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 52 days | ||
| Secondary | Number of participants with adverse events leading to discontinuation | Up to 52 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 52 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 52 days | ||
| Secondary | Measurement of left ventricular ejection fraction (LVEF) | Up to 52 days | ||
| Secondary | Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) | Up to 52 days | ||
| Secondary | Measurement of left ventricular fractional shortening (LVFS) | Up to 52 days | ||
| Secondary | Measurement of left ventricular global longitudinal strain (LV GLS) | Up to 52 days | ||
| Secondary | Measurement of left ventricle stroke volume (LVSV) | Up to 52 days | ||
| Secondary | Number of participants with physical exam abnormalities | Up to 52 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 52 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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