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

NCT ID: NCT07226817

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-12

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment B

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment C

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment D

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment E

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment F

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment G

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986435

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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MYK-224

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Miami, Florida, United States

Site Status

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Site 0001

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CV029-1024

Identifier Type: -

Identifier Source: org_study_id