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Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

NCT ID: NCT06577259

Last Updated: 2025-03-14

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-03

Study Completion Date

2025-02-19

Brief Summary

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The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A: BMS-986435 Reference Dose 1

Group Type ACTIVE_COMPARATOR

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment B: BMS-986435 Test Dose 1

Group Type EXPERIMENTAL

BMS-986435

Intervention Type DRUG

Specified dose on specified days

Treatment C: BMS-986435 Test Dose 2

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

Eligibility Criteria

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Inclusion Criteria

* Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive.
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
* Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.

Exclusion Criteria

* Any acute or chronic medical illness.
* History of heart disease.
* Prior exposure to BMS-986435.
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

San Antonio, Texas, United States

Site Status

Countries

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United States

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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CV029-1018

Identifier Type: -

Identifier Source: org_study_id

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