A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405543
• Other study ID #: CV029-014
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: January 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 9, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments

• Must have documented left Ventricular Ejection Fraction (LVEF) =60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion Criteria:

• Any acute or chronic medical illness

• History of heart disease

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• MYK-224
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to 72 days
Primary	Time of maximum observed concentration (Tmax)		Up to 72 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 72 days
Secondary	Number of participants with adverse events (AEs)		Up to 130 days
Secondary	Number of participants with serious adverse events (SAEs)		Up to 130 days
Secondary	Number of participants with adverse events leading to discontinuation		Up to 130 days
Secondary	Number of participants with vital sign abnormalities		Up to 72 days
Secondary	Number of participants with physical exam abnormalities		Up to 72 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 72 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 72 days
Secondary	Measurement of left ventricular ejection fraction (LVEF)		Up to 72 days
Secondary	Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)		Up to 72 days
Secondary	Measurement of left ventricular fractional shortening (LVFS)		Up to 72 days
Secondary	Measurement of left ventricular global longitudinal strain (LV GLS)		Up to 72 days
Secondary	Measurement of left ventricle stroke volume (LVSV)		Up to 72 days
Secondary	Measurement of lateral and septal early diastolic mitral annular velocity (e')		Up to 72 days
Secondary	Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')		Up to 72 days
Secondary	Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)		Up to 72 days
Secondary	Measurement of left ventricular (LV) mass index		Up to 72 days
Secondary	Measurement of left atrial volume index		Up to 72 days
Secondary	Measurement of interventricular septal thickness		Up to 72 days
Secondary	Measurement of posterior wall thickness		Up to 72 days
Secondary	Measurement of LV end diastolic volume		Up to 72 days
Secondary	Measurement of LV end diastolic volume index		Up to 72 days
Secondary	Measurement of LV end systolic volume		Up to 72 days
Secondary	Measurement of LV end systolic volume index		Up to 72 days
Secondary	Relative bioavailability of test formulation compared to the reference formulation based on Cmax		Up to 72 days
Secondary	Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)		Up to 72 days
Secondary	Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)		Up to 72 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting