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

NCT04444050 | Completed Phase 1 FDA Drug

• 1 other identifier: CV023-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Keywords

Healthy participants

Outcome Measures

Primary Outcomes (4)

• Number of participants with adverse events (AEs)

  Up to 13 months

• Number of participants with clinical laboratory abnormalities

  Up to 46 days

• Number of participants with vital sign abnormalities

  Up to 46 days

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to 46 days

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax)

  Up to 17 days

• 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

Study Arms (16)

Part 1 Single Ascending Dose (SAD): Panel 1

EXPERIMENTAL

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

Part 1 SAD: Panel 2

EXPERIMENTAL

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

Part 1 SAD: Panel 3

EXPERIMENTAL

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

Part 1 SAD: Panel 4

EXPERIMENTAL

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

Part 1 SAD: Panel 5

EXPERIMENTAL

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

Part 1 SAD: Panel 6

EXPERIMENTAL

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

Part 1 SAD: Optional Split-dose Panel

EXPERIMENTAL

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

Part 2 Multiple Ascending Dose (MAD): Panel 1

EXPERIMENTAL

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

Part 2 MAD: Panel 2

EXPERIMENTAL

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

Part 2 MAD: Panel 3

EXPERIMENTAL

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

Part 2 MAD: Panel 4

EXPERIMENTAL

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

Part 2 MAD: Optional (to be determined) Panel

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Part 3 J-MAD: Panel 2

EXPERIMENTAL

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

Part 3 J-MAD: Panel 3

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

BMS-986331 DRUG

Specified dose on specified days

Part 1 SAD: Optional Split-dose Panel; Part 1 SAD: Panel 2; Part 1 SAD: Panel 3; Part 1 SAD: Panel 4; Part 1 SAD: Panel 5; Part 1 SAD: Panel 6; Part 1 Single Ascending Dose (SAD): Panel 1; Part 2 MAD: Optional (to be determined) Panel; Part 2 MAD: Panel 2; Part 2 MAD: Panel 3; Part 2 MAD: Panel 4; Part 2 Multiple Ascending Dose (MAD): Panel 1; Part 3 J-MAD: Optional (to be determined) Panel; Part 3 J-MAD: Panel 2; Part 3 J-MAD: Panel 3; Part 3 MAD in Japanese Participants (J-MAD): Panel 1

Placebo, Matching BMS-986331 OTHER

Specified dose on specified days

Part 1 SAD: Optional Split-dose Panel; Part 1 SAD: Panel 2; Part 1 SAD: Panel 3; Part 1 SAD: Panel 4; Part 1 SAD: Panel 5; Part 1 SAD: Panel 6; Part 1 Single Ascending Dose (SAD): Panel 1; Part 2 MAD: Optional (to be determined) Panel; Part 2 MAD: Panel 2; Part 2 MAD: Panel 3; Part 2 MAD: Panel 4; Part 2 Multiple Ascending Dose (MAD): Panel 1; Part 3 J-MAD: Optional (to be determined) Panel; Part 3 J-MAD: Panel 2; Part 3 J-MAD: Panel 3; Part 3 MAD in Japanese Participants (J-MAD): Panel 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

ICON (LPRA) - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 23, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (2)