Clinical Trials/NCT04444050

NCT04444050CompletedPhase 1

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

Bristol-Myers Squibb2 sites in 1 country48 target enrollmentStarted: June 23, 2020Last updated: October 20, 2022

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 48
Locations: 2
Primary Endpoint: Number of participants with adverse events (AEs)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential
Primary Purpose: Basic Science
Masking: Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts 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/exclusion criteria apply

Arms & Interventions

Part 3 J-MAD: Panel 3

Experimental

Intervention: BMS-986331 (Drug)

Part 1 Single Ascending Dose (SAD): Panel 1

Experimental

Intervention: BMS-986331 (Drug)

Part 1 Single Ascending Dose (SAD): Panel 1

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Panel 2

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Panel 2

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Panel 3

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Panel 3

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Panel 4

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Panel 4

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Panel 5

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Panel 5

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Panel 6

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Panel 6

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 1 SAD: Optional Split-dose Panel

Experimental

Intervention: BMS-986331 (Drug)

Part 1 SAD: Optional Split-dose Panel

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 2 Multiple Ascending Dose (MAD): Panel 1

Experimental

Intervention: BMS-986331 (Drug)

Part 2 Multiple Ascending Dose (MAD): Panel 1

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 2 MAD: Panel 2

Experimental

Intervention: BMS-986331 (Drug)

Part 2 MAD: Panel 2

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 2 MAD: Panel 3

Experimental

Intervention: BMS-986331 (Drug)

Part 2 MAD: Panel 3

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 2 MAD: Panel 4

Experimental

Intervention: BMS-986331 (Drug)

Part 2 MAD: Panel 4

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 2 MAD: Optional (to be determined) Panel

Experimental

Intervention: BMS-986331 (Drug)

Part 2 MAD: Optional (to be determined) Panel

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

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

Experimental

Intervention: BMS-986331 (Drug)

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

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 3 J-MAD: Panel 2

Experimental

Intervention: BMS-986331 (Drug)

Part 3 J-MAD: Panel 2

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Part 3 J-MAD: Panel 3

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

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

Experimental

Intervention: BMS-986331 (Drug)

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

Experimental

Intervention: Placebo, Matching BMS-986331 (Other)

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time Frame: Up to 13 months

Number of participants with clinical laboratory abnormalities

Time Frame: Up to 46 days

Number of participants with vital sign abnormalities

Time Frame: Up to 46 days

Number of participants with electrocardiogram (ECG) abnormalities

Time Frame: Up to 46 days

Secondary Outcomes

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

Investigators

Sponsor

Bristol-Myers Squibb

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (2)

Loading locations...

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