A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986166; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04965402

IM018-007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese (both biological parents are ethnically Japanese)
• Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations
• Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2

Exclusion criteria

• Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor
• History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)
• Inability to tolerate oral medication
• Women who are of childbearing potential, breastfeeding, or lactating

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 3 patient groups, including a placebo group

Panel 1: Dose 1

Experimental group

Treatment:

Drug: BMS-986166

Panel 2: Dose 2

Experimental group

Treatment:

Drug: BMS-986166

Placebo

Placebo Comparator group

Treatment:

Other: Placebo