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

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

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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