West Coast Clinical Trials Global
Cypress, California, 90630, United States
Completed
NCT Number: NCT04965402
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BMS-986166
DrugSpecified dose on specified days
Placebo
OtherSpecified dose on specified days
Primary outcomes
-
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
Time frame: Day 1, Day 28
-
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Time frame: Day 1, Day 28
-
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Day 1, Day 28
-
PK parameters of BMT-121795: Cmax
Time frame: Day 1, Day 28
-
PK parameters of BMT-121795: Tmax
Time frame: Day 1, Day 28
-
PK parameters of BMT-121795: AUC(TAU)
Time frame: Day 1, Day 28
Secondary outcomes
-
Incidence of all adverse events (AEs)
Time frame: Up to 77 days
-
Severity of all AEs
Time frame: Up to 77 days
-
Outcome of all AEs
Time frame: Up to 77 days
-
Incidence of all serious adverse events (SAEs)
Time frame: Up to 77 days
-
Severity of all SAEs
Time frame: Up to 77 days
-
Outcome of all SAEs
Time frame: Up to 77 days
-
Severity of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
-
Investigator causality assessment of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
-
Outcomes of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
-
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 77 days
-
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 77 days
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
-
Incidence of clinically significant changes in continuous cardiac monitoring data
Time frame: Up to 77 days
-
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 77 days
-
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 77 days
-
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 77 days
-
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 77 days
-
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
-
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
-
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in vital signs: Body temperature
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in vital signs: Heart rate
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
-
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Jul 16, 2021
- Registry last updated
- Mar 9, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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