Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants

October 19, 2022 updated by: Bristol-Myers Squibb

Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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
        • Local Institution - 0001
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • ICON (LPRA) - Lenexa

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
  • A body mass index of 18 - 32 kg/m2, inclusive
  • Women and men must agree to follow specific methods of contraception, if applicable

For J-MAD Part 3

  • Must be Japanese (both biological parents are ethnically Japanese)

Exclusion Criteria:

  • Women who are of childbearing potential
  • Women who are pregnant or breastfeeding
  • 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 surgery within 12 weeks 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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Part 1 Single Ascending Dose (SAD): Panel 1
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Panel 2
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Panel 3
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Panel 4
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Panel 5
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Panel 6
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 1 SAD: Optional Split-dose Panel
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 2 Multiple Ascending Dose (MAD): Panel 1
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 2 MAD: Panel 2
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 2 MAD: Panel 3
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 2 MAD: Panel 4
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 2 MAD: Optional (to be determined) Panel
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 3 MAD in Japanese Participants (J-MAD): Panel 1
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 3 J-MAD: Panel 2
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 3 J-MAD: Panel 3
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days
EXPERIMENTAL: Part 3 J-MAD: Optional (to be determined) Panel
Drug: BMS-986331
Specified dose on specified days
Other: Placebo, Matching BMS-986331
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 13 months
Up to 13 months
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 46 days
Up to 46 days
Number of participants with vital sign abnormalities
Time Frame: Up to 46 days
Up to 46 days
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 46 days
Up to 46 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Up to 17 days
Up to 17 days
Time to reach Cmax in plasma (Tmax)
Time Frame: Up to 17 days
Up to 17 days
Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]
Time Frame: Up to 17 days
Up to 17 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)

June 23, 2020

Primary Completion (ACTUAL)

May 19, 2021

Study Completion (ACTUAL)

May 19, 2021

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CV023-005

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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