NCT05405543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

June 1, 2022

Last Update Submit

January 12, 2023

Conditions

Healthy Volunteers

Keywords

MYK-224Healthy Participants of Japanese Ethnicity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (26)

  • 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

  • +21 more secondary outcomes

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: MYK-224Other: Placebo

Arm 2

EXPERIMENTAL
Drug: MYK-224Other: Placebo

Arm 3

EXPERIMENTAL
Drug: MYK-224Other: Placebo

Arm 4

EXPERIMENTAL
Drug: MYK-224Other: Placebo

Interventions

MYK-224DRUG

Specified dose on specified days

Also known as: BMS-986435
Arm 1Arm 2Arm 3Arm 4
PlaceboOTHER

Specified dose on specified days

Arm 1Arm 2Arm 3Arm 4

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Any acute or chronic medical illness
  • History of heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

July 12, 2022

Primary Completion

November 16, 2022

Study Completion

December 9, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

US(1)