A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

NCT06476821 | Completed Phase 1 FDA Drug

• 1 other identifier: CV029-1010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Up to Day 30

• Time of maximum observed concentration (Tmax)

  Up to Day 30

• Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

  Up to Day 30

Secondary Outcomes (24)

• Number of participants with Adverse Events

  From date of written consent up to 28 days post last dose

• Number of participants with Serious Adverse Events

  From date of written consent up to 28 days post last dose

• Number of participants with AEs leading to discontinuation

  From date of written consent up to 28 days post last dose

• Number of participants with vital sign abnormalities

  Up to Day 31

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to Day 31

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: BMS-986435

Arm 2

EXPERIMENTAL

Drug: BMS-986435

Interventions

BMS-986435 DRUG

Specified dose on specified days

Also known as: MYK-224

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening.
• Participants must be Chinese (both biological parents are ethnically Chinese).
• Participant has documented 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.
• Head injury in the last 2 years, intracranial tumor, or aneurysm.
• History of malignancy of any type, except in situ cervical cancer \> 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers \> 2 years prior to the screening visit.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Xuhui District, Shanghai Municipality, 200032, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 27, 2024
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (1)