MedDataX Logo

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

NCT ID: NCT04444050

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2021-05-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

NCT05813717

Healthy Volunteers
COMPLETED PHASE1

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

NCT05546151

Healthy Participants
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants

NCT04965402

Healthy Volunteers
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants

NCT05760937

Healthy Participants
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity

NCT06084598

Healthy Participants
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1 Single Ascending Dose (SAD): Panel 1

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Panel 2

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Panel 3

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Panel 4

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Panel 5

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Panel 6

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 1 SAD: Optional Split-dose Panel

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 2 Multiple Ascending Dose (MAD): Panel 1

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 2 MAD: Panel 2

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 2 MAD: Panel 3

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 2 MAD: Panel 4

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 2 MAD: Optional (to be determined) Panel

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 3 MAD in Japanese Participants (J-MAD): Panel 1

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 3 J-MAD: Panel 2

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 3 J-MAD: Panel 3

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Part 3 J-MAD: Optional (to be determined) Panel

Group Type EXPERIMENTAL

BMS-986331

Intervention Type DRUG

Specified dose on specified days

Placebo, Matching BMS-986331

Intervention Type OTHER

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986331

Specified dose on specified days

Intervention Type DRUG

Placebo, Matching BMS-986331

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Anaheim, California, United States

Site Status

ICON (LPRA) - Lenexa

Lenexa, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CV023-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
NCT03198182 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.
NCT07283263 RECRUITING PHASE1
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
NCT04082741 WITHDRAWN PHASE1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
NCT06411730 COMPLETED PHASE1
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
NCT03634995 COMPLETED PHASE1
A Study of Experimental Medication BMS-986235 in Healthy Subjects
NCT03335553 COMPLETED PHASE1
A Study of Experimental Medication BMS-986278 Given to Healthy Participants
NCT03429933 COMPLETED PHASE1
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
NCT02790125 COMPLETED PHASE1
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects
NCT02257151 COMPLETED PHASE1
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants
NCT05805904 COMPLETED PHASE1
Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects
NCT01605994 COMPLETED PHASE1
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
NCT02145234 COMPLETED PHASE1
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
NCT02932969 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
NCT06086886 COMPLETED PHASE1
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
NCT02293629 COMPLETED PHASE1
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
NCT06877702 COMPLETED PHASE1
A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants
NCT05517837 TERMINATED EARLY_PHASE1
An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
NCT04008992 COMPLETED PHASE1
Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
NCT02327273 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants
NCT06476821 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
NCT04736134 COMPLETED PHASE1
Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
NCT00959803 COMPLETED PHASE1
A Study to Test the Safety and Tolerability and Pharmacokinetics of Single Doses of UCB0107 in Healthy Japanese Subjects
NCT03605082 COMPLETED PHASE1
A Study in Healthy Men to Test How Well Different Doses of BI 1584862 Are Tolerated
NCT06148948 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
NCT05806359 COMPLETED PHASE1