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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04444050

Enrollment

Registered

2020-06-23

Start date

2020-06-23

Completion date

2021-05-19

Last updated

2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Healthy participants

Brief summary

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.

Interventions

DRUGBMS-986331

Specified dose on specified days

OTHERPlacebo, Matching BMS-986331

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
Time to reach Cmax in plasma (Tmax)	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)]	Up to 17 days
Maximum plasma concentration (Cmax)	Up to 17 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026