A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants

NCT ID: NCT06877702

Last Updated: 2026-01-20

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

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-19

Study Completion Date

2025-12-17

Brief Summary

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The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

Detailed Description

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Conditions

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Healthy Volunteers

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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Part 1: Sequence 1

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 1: Sequence 2

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 1: Sequence 3

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 2: Treatment A

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 2: Treatment B

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 2: Optional Treatment C

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 2: Optional Treatment D

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Part 2: Optional Treatment E

Group Type EXPERIMENTAL

BMS-986460

Intervention Type DRUG

Specified dose on specified days.

Interventions

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BMS-986460

Specified dose on specified days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
* Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
* Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.

Exclusion Criteria

* Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
* Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
* Participants with history of anaphylactic reactions are excluded.
* Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
* Participants with history of Gilbert's syndrome are excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

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

Lenexa, Kansas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA125-1018

Identifier Type: -

Identifier Source: org_study_id

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