A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.

Official Title
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A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986172
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee. Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for <10 years. BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2. Exclusion Criteria: Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal. Any significant acute or chronic medical condition 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. History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee. Any significant acute or chronic medical illness. History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment 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: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: SAD<br>SAD = Single Ascending Dose | Drug: BMS-986172<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part B: MAD<br>MAD = Multiple Ascending Dose | Drug: BMS-986172<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part C: JMAD<br>JMAD= Japanese Multiple Ascending Dose | Drug: BMS-986172<br>* Specified dose on specified days<br>Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part D: FE/BA<br>FE/BA = Food Effect/Relative Bioavailability | Drug: BMS-986172<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 |
| --- | --- | --- |
| Incidence of non-serious Adverse Events (AEs) |  | Up to 35 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 35 days | 
| Incidence of AEs leading to discontinuation of study treatment |  | Up to 35 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 28 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 28 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 28 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 28 days | 
| Incidence of clinically significant changes in physical examination |  | Up to 28 days | 
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests |  | Up to 28 days | 
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests |  | Up to 28 days | 
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests |  | Up to 28 days | 
| Incidence of clinically significant changes in clinical laboratory values: Serology tests |  | Up to 28 days | 
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of BMS-986172 |  | Up to 28 days | 
| Maximum observed plasma concentration (Cmax) |  | Up to 28 days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |  | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, BMS-986172