A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: BMS-986447

Study type: Interventional

Funder types: Industry

Identifiers

NCT05760937

IM054-003

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive.
• Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
• A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.

Exclusion criteria

• Participant has any condition that confounds the ability to interpret data from the study.
• Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
• Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

BMS-986447

Experimental group

Treatment:

Drug: BMS-986447

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo