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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 29, 2021

Interventions

  • Drug: BMS-986337
    • Specified Dose on Specified Days
  • Other: BMS-986337 Placebo
    • Specified Dose on Specified Days
  • Biological: Famotidine
    • Specified Dose on Specified Days

Arms, Groups and Cohorts

  • Experimental: Part A Single Ascending Dose (SAD) Cohort A1
  • Experimental: Part A SAD Cohort A2
  • Experimental: Part A SAD Cohort A3
  • Experimental: Part A SAD Cohort A4
  • Experimental: Part A SAD Cohort A5
  • Experimental: Part A SAD Cohort A6
  • Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1
  • Experimental: Part B MAD Cohort B2
  • Experimental: Part B MAD Cohort B3
  • Experimental: Part B MAD Cohort B4
  • Experimental: Part C MAD in Japanese Healthy participants Cohort C1
  • Experimental: Part C MAD in Japanese Healthy participants Cohort C2
  • Experimental: Part C MAD in Japanese Healthy participants Cohort C3

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Adverse Events (AEs)
    • Time Frame: Up to 30 days
  • Incidence of Serious Adverse Events (SAEs)
    • Time Frame: Up to 81 days
  • Incidence of AEs leading to discontinuation
    • Time Frame: Up to 30 days
  • Number of clinically significant changes in clinical laboratory values: Hematology tests
    • Time Frame: Up to 51 days
  • Number of clinically significant changes in clinical laboratory values: Urinalysis tests
    • Time Frame: Up to 51 days
  • Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
    • Time Frame: Up to 51 days
  • Number of clinically significant changes from baseline in vital signs: Heart Rate
    • Time Frame: Up to 51 days
  • Number of clinically significant changes from baseline in vital signs: Body Temperature
    • Time Frame: Up to 51 days
  • Number of clinically significant changes from baseline in vital signs: Blood Pressure
    • Time Frame: Up to 51 days
  • Number of clinically significant changes from baseline in vital signs: Respiratory Rate
    • Time Frame: Up to 51 days
  • Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
    • Time Frame: Up to 51 days
  • Number of clinically significant changes from baseline in physical examinations
    • Time Frame: Up to 51 days
  • Number of clinically significant changes in ECG parameters: PR interval
    • Time Frame: Up to 51 days
    • PR interval is the time from the onset of the P wave to the start of the QRS complex
  • Number of clinically significant changes in ECG parameters: QRS duration
    • Time Frame: Up to 51 days
    • QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
  • Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia’s)
    • Time Frame: Up to 51 days
    • 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.
  • Number of clinically significant changes in ECG parameters: QT interval
    • Time Frame: Up to 51 days
    • The QT interval is the time from the start of the Q wave to the end of the T wave.

Participating in This Clinical Trial

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
  • Overall Contact(s)
    • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, Clinical.Trials@bms.com

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