A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

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-986337 in healthy participants and in healthy Japanese participants.

Official Title
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A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986337
* Other: BMS-986337 Placebo
* Biological: Famotidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese) Body mass index (BMI) of 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening; BMI = weight (kg)/height (m)^2 Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Women who are of childbearing potential Women who are breastfeeding Prior exposure to BMS-986278 Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2 Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Single Ascending Dose (SAD) Cohort A1<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A SAD Cohort A2<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A SAD Cohort A3<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A SAD Cohort A4<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A SAD Cohort A5<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part A SAD Cohort A6<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Biological: Famotidine<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B MAD Cohort B2<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B MAD Cohort B3<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B MAD Cohort B4<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part C MAD in Japanese Healthy participants Cohort C1<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part C MAD in Japanese Healthy participants Cohort C2<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part C MAD in Japanese Healthy participants Cohort C3<br> | Drug: BMS-986337<br>* Specified Dose on Specified Days<br>Other: BMS-986337 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 |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 30 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 81 days | 
| Incidence of AEs leading to discontinuation |  | Up to 30 days | 
| Number of clinically significant changes in clinical laboratory values: Hematology tests |  | Up to 51 days | 
| Number of clinically significant changes in clinical laboratory values: Urinalysis tests |  | Up to 51 days | 
| Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests |  | Up to 51 days | 
| Number of clinically significant changes from baseline in vital signs: Heart Rate |  | Up to 51 days | 
| Number of clinically significant changes from baseline in vital signs: Body Temperature |  | Up to 51 days | 
| Number of clinically significant changes from baseline in vital signs: Blood Pressure |  | Up to 51 days | 
| Number of clinically significant changes from baseline in vital signs: Respiratory Rate |  | Up to 51 days | 
| Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR) |  | Up to 51 days | 
| Number of clinically significant changes from baseline in physical examinations |  | Up to 51 days | 
| Number of clinically significant changes in ECG parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 51 days | 
| Number of clinically significant changes in ECG parameters: QRS duration | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 51 days | 
| Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's) | 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 51 days | 
| Number of clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave. | Up to 51 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers