A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

June 20, 2023 updated by: Bristol-Myers Squibb

A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent

The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials Llc

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant must be of Japanese descent (both biological parents are ethnically Japanese).
  • In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
  • Women should be of non-childbearing potential.

Exclusion Criteria:

  • Any significant acute or chronic medical illness.
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
  • Any major surgery within 90 days of study drug administration.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort J1
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days
Experimental: Cohort J2
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days
Experimental: Cohort J3
Drug: BMS-986322
Specified dose on specified days
Other: Placebo for BMS-986322
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of deaths
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with AEs
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with physical examination abnormalities
Time Frame: Up to 7 weeks
Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 7 weeks
Up to 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax)
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Time Frame: Day 1 and Day 14
Day 1 and Day 14

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, 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 28, 2022

Primary Completion (Actual)

April 7, 2023

Study Completion (Actual)

April 7, 2023

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IM032-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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