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Recruiting

Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants - CV023-005

Updated: 22 June, 2020   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • 2

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1 SAD: Optional Split-dose Panel
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 1 SAD: Panel 2
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 1 SAD: Panel 3
Other: Placebo, Matching BMS-986331 Drug: BMS-986331
Experimental: Part 1 SAD: Panel 4
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 1 SAD: Panel 5
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 1 SAD: Panel 6
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 1 Single Ascending Dose (SAD): Panel 1
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 2 MAD: Optional (to be determined) Panel
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 2 MAD: Panel 2
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 2 MAD: Panel 3
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 2 MAD: Panel 4
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 2 Multiple Ascending Dose (MAD): Panel 1
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 3 J-MAD: Optional (to be determined) Panel
Other: Placebo, Matching BMS-986331 Drug: BMS-986331
Experimental: Part 3 J-MAD: Panel 2
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 3 J-MAD: Panel 3
Drug: BMS-986331 Other: Placebo, Matching BMS-986331
Experimental: Part 3 MAD in Japanese Participants (J-MAD): Panel 1
Drug: BMS-986331 Other: Placebo, Matching BMS-986331

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com