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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: BMS-986166
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel 1: Dose 1<br> | Drug: BMS-986166<br>* Specified dose on specified days<br>|
| Experimental: Panel 2: Dose 2<br> | Drug: BMS-986166<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax) |  | Day 1, Day 28 | 
| PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax) |  | Day 1, Day 28 | 
| PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU)) |  | Day 1, Day 28 | 
| PK parameters of BMT-121795: Cmax |  | Day 1, Day 28 | 
| PK parameters of BMT-121795: Tmax |  | Day 1, Day 28 | 
| PK parameters of BMT-121795: AUC(TAU) |  | Day 1, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events (AEs) |  | Up to 77 days | 
| Severity of all AEs |  | Up to 77 days | 
| Outcome of all AEs |  | Up to 77 days | 
| Incidence of all serious adverse events (SAEs) |  | Up to 77 days | 
| Severity of all SAEs |  | Up to 77 days | 
| Outcome of all SAEs |  | Up to 77 days | 
| Severity of all AEs regardless of seriousness criteria |  | Up to 77 days | 
| Investigator causality assessment of all AEs regardless of seriousness criteria |  | Up to 77 days | 
| Outcomes of all AEs regardless of seriousness criteria |  | Up to 77 days | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 77 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 77 days | 
| Incidence of clinically significant changes in ECG parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization | Up to 77 days | 
| Incidence of clinically significant changes in ECG parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 77 days | 
| Incidence of clinically significant changes in ECG parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 77 days | 
| Incidence of clinically significant changes in continuous cardiac monitoring data |  | Up to 77 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 77 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 77 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 77 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 77 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 77 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to 77 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in ECG parameters: QT interval |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in vital signs: Body temperature |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in vital signs: Blood pressure |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in vital signs: Heart rate |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests |  | Up to 77 days | 
| Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests |  | Up to 77 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986166, Japan