An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Other: Placebo
Drug: BMS-986256

Study type

Interventional

Funder types

Industry

Identifiers

NCT03634995
2017-003729-13 (EudraCT Number)
IM026-002

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.

Enrollment

118 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

  • Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
  • Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
  • A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening

Exclusion Criteria:

  • Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
  • Inability to tolerate oral medication
  • Inability to tolerate venipuncture, or inadequate venous access

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

118 participants in 3 patient groups

Single Dose
Experimental group
Description:
Ascending single doses of BMS-986256
Treatment:
Drug: BMS-986256
Other: Placebo
Multiple Dose
Experimental group
Description:
Ascending multiple doses of BMS-986256
Treatment:
Drug: BMS-986256
Other: Placebo
Sequential Dose
Experimental group
Description:
Sequential multiple doses of BMS-986256
Treatment:
Drug: BMS-986256
Other: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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