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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05405543

Collaborator

(none)

Enrollment

Location

Arms

10.7

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: MYK-224 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

Nov 28, 2022

Anticipated Study Completion Date :

May 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: MYK-224 Specified dose on specified days Other Names: BMS-986435 Other: Placebo Specified dose on specified days
Experimental: Arm 2	Drug: MYK-224 Specified dose on specified days Other Names: BMS-986435 Other: Placebo Specified dose on specified days
Experimental: Arm 3	Drug: MYK-224 Specified dose on specified days Other Names: BMS-986435 Other: Placebo Specified dose on specified days
Experimental: Arm 4	Drug: MYK-224 Specified dose on specified days Other Names: BMS-986435 Other: Placebo Specified dose on specified days

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) [Up to 72 days]
Time of maximum observed concentration (Tmax) [Up to 72 days]
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 Outcome Measures

Number of participants with adverse events (AEs) [Up to 130 days]
Number of participants with serious adverse events (SAEs) [Up to 130 days]
Number of participants with adverse events leading to discontinuation [Up to 130 days]
Number of participants with vital sign abnormalities [Up to 72 days]
Number of participants with physical exam abnormalities [Up to 72 days]
Number of participants with clinical laboratory abnormalities [Up to 72 days]
Number of participants with electrocardiogram (ECG) abnormalities [Up to 72 days]
Measurement of left ventricular ejection fraction (LVEF) [Up to 72 days]
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) [Up to 72 days]
Measurement of left ventricular fractional shortening (LVFS) [Up to 72 days]
Measurement of left ventricular global longitudinal strain (LV GLS) [Up to 72 days]
Measurement of left ventricle stroke volume (LVSV) [Up to 72 days]
Measurement of lateral and septal early diastolic mitral annular velocity (e') [Up to 72 days]
Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e') [Up to 72 days]
Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio) [Up to 72 days]
Measurement of left ventricular (LV) mass index [Up to 72 days]
Measurement of left atrial volume index [Up to 72 days]
Measurement of interventricular septal thickness [Up to 72 days]
Measurement of posterior wall thickness [Up to 72 days]
Measurement of LV end diastolic volume [Up to 72 days]
Measurement of LV end diastolic volume index [Up to 72 days]
Measurement of LV end systolic volume [Up to 72 days]
Measurement of LV end systolic volume index [Up to 72 days]
Relative bioavailability of test formulation compared to the reference formulation based on Cmax [Up to 72 days]
Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T) [Up to 72 days]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Anaheim	California	United States	92801

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT05405543

Other Study ID Numbers:

CV029-014

First Posted:

Jun 6, 2022

Last Update Posted:

Jun 6, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bristol-Myers Squibb

MYK-224

Healthy Participants of Japanese Ethnicity

Study Results

No Results Posted as of Jun 6, 2022