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A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

NCT ID: NCT06144697

Last Updated: 2025-02-06

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-10-16

Brief Summary

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The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.

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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

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]

Group Type EXPERIMENTAL

BMS-986465

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]

Group Type EXPERIMENTAL

BMS-986465

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Pegasys

Intervention Type DRUG

Specified dose on specified days

Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]

Group Type EXPERIMENTAL

BMS-986465

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

Group Type EXPERIMENTAL

BMS-986465

Intervention Type DRUG

Specified dose on specified days

Famotidine

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986465

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Pegasys

Specified dose on specified days

Intervention Type DRUG

Famotidine

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female (i e, women not of childbearing potential) participants
* Body Mass Index (BMI) of 18 to 32 kg\^m2 and total body weight ≥ 50 kg
* Parts A, B, and D: Participants without restriction on ethnicity
* Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)

Exclusion Criteria

* Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
* Any major surgery within 3 months of study intervention administration
* Participation in another clinical trial concurrent with this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Anaheim, California, United States

Site Status

Local Institution - 0003

Austin, 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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CN009-1024

Identifier Type: -

Identifier Source: org_study_id

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