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

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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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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