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

January 12, 2023 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 72 days
Up to 72 days
Time of maximum observed concentration (Tmax)
Time Frame: Up to 72 days
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])
Time Frame: Up to 72 days
Up to 72 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV029-014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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