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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Other: Placebo, Matching BMS-986331; Drug: BMS-986331

Study type: Interventional

Funder types: Industry

Identifiers

NCT04444050

CV023-005

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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48 participants in 16 patient groups

Part 1 Single Ascending Dose (SAD): Panel 1

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Panel 2

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Panel 3

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Panel 4

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Panel 5

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Panel 6

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 1 SAD: Optional Split-dose Panel

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 2 Multiple Ascending Dose (MAD): Panel 1

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 2 MAD: Panel 2

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 2 MAD: Panel 3

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 2 MAD: Panel 4

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 2 MAD: Optional (to be determined) Panel

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

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

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 3 J-MAD: Panel 2

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

Part 3 J-MAD: Panel 3

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331

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

Experimental group

Treatment:

Drug: BMS-986331

Other: Placebo, Matching BMS-986331