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

February 9, 2022 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • ICON Plc (PRA Health Sciences) - Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Single Ascending Dose (SAD) Cohort A1
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part A SAD Cohort A2
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part A SAD Cohort A3
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part A SAD Cohort A4
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part A SAD Cohort A5
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part A SAD Cohort A6
Drug: BMS-986337
Specified Dose on Specified Days
Biological: Famotidine
Specified Dose on Specified Days
Experimental: Part B Multiple Ascending Dose (MAD) Cohort B1
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part B MAD Cohort B2
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part B MAD Cohort B3
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part B MAD Cohort B4
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part C MAD in Japanese Healthy participants Cohort C1
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part C MAD in Japanese Healthy participants Cohort C2
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days
Experimental: Part C MAD in Japanese Healthy participants Cohort C3
Drug: BMS-986337
Specified Dose on Specified Days
Other: BMS-986337 Placebo
Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 30 days
Up to 30 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 81 days
Up to 81 days
Incidence of AEs leading to discontinuation
Time Frame: Up to 30 days
Up to 30 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Time Frame: Up to 51 days
Up to 51 days
Number of clinically significant changes from baseline in physical examinations
Time Frame: Up to 51 days
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
Up to 51 days
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
Up to 51 days
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.
Up to 51 days
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.
Up to 51 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 11, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM037-009
  • 2019-004518-32 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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