A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

NCT07226817 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CV029-1024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Up to Day 28

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

  Up to Day 28

• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Up to Day 28

Secondary Outcomes (11)

• Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))

  Up to Day 28

• Time of maximum observed concentration (Tmax)

  Up to Day 28

• Half-life (T-HALF)

  Up to Day 28

• Apparent total body clearance (CLT/F)

  Up to Day 28

• Volume of distribution of terminal phase (Vz/F)

  Up to Day 28

Study Arms (7)

Treatment A

EXPERIMENTAL

Drug: BMS-986435

Treatment B

EXPERIMENTAL

Drug: BMS-986435

Treatment C

EXPERIMENTAL

Drug: BMS-986435

Treatment D

EXPERIMENTAL

Drug: BMS-986435

Treatment E

EXPERIMENTAL

Drug: BMS-986435

Treatment F

EXPERIMENTAL

Drug: BMS-986435

Treatment G

EXPERIMENTAL

Drug: BMS-986435

Interventions

BMS-986435 DRUG

Specified dose on specified days

Also known as: MYK-224

Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment G

Eligibility Criteria

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

You may qualify if:

• Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive
• Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments
• Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Quotient Miami

Miami, Florida, 33126, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 10, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

US (1)