A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
- Registration Number
- NCT04965402
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel 1: Dose 1 BMS-986166 - Panel 2: Dose 2 BMS-986166 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax) Day 1, Day 28 Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax) 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: Tmax Day 1, Day 28 PK parameters of BMT-121795: AUC(TAU) Day 1, Day 28 PK parameters of BMT-121795: Cmax Day 1, Day 28
- Secondary Outcome Measures
Name Time Method 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 Severity of all SAEs Up to 77 days Outcome of all SAEs Up to 77 days Incidence of clinically significant changes in ECG parameters: QRS interval Up to 77 days QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in ECG parameters: QT interval Up to 77 days QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in ECG parameters: QTcF interval Up to 77 days QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
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 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 Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 77 days PR interval: The time from the onset of the P wave to the start of the QRS complex
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
Trial Locations
- Locations (1)
West Coast Clinical Trials Global
🇺🇸Cypress, California, United States