Healthy Volunteers
Conditions
Keywords
BMS-986166, Japan
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.
Interventions
DRUGBMS-986166
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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 from baseline values in vital signs: Blood pressure | Up to 77 days | — |
| 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 from baseline values in vital signs: Heart rate | 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 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 | — |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 77 days | — |
| Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate | 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 | — |
Countries
United States
Outcome results
None listed