A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2023-05-23

Brief Summary

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The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese participants.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days.

Placebo

Intervention Type DRUG

Specified dose on specified days

Group 2

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days.

Placebo

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986278

Specified dose on specified days.

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants must be Chinese (both biological parents are ethnically Chinese).
* Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
* Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height \[m\])2.
* Body weight ≥ 50 kg

Exclusion Criteria

* Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome)
* Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable)
* Women who are of childbearing potential
* Women who are breastfeeding
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate \< 90 mL/min/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes