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

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

Official Title
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A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986447
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986447<br> | Drug: BMS-986447<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Up to 59 days | 
| Number of Participants with Serious AEs (SAEs) |  | Up to 59 days | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Up to 34 days | 
| Number of Participants with Vital Sign Abnormalities |  | Up to 35 days | 
| Number of Participants with Physical Examination Abnormalities |  | Up to 35 days | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities |  | Up to 34 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 72 hours postdose | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 72 hours postdose | 
| Apparent terminal phase half-life (T-Half) |  | Up to 72 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986447