Clinical trial NCT04965402: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986166
Japan
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
timeFrame: Day 1, Day 28
measure: PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
timeFrame: Day 1, Day 28
measure: PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
timeFrame: Day 1, Day 28
measure: PK parameters of BMT-121795: Cmax
timeFrame: Day 1, Day 28
measure: PK parameters of BMT-121795: Tmax
timeFrame: Day 1, Day 28
measure: PK parameters of BMT-121795: AUC(TAU)
timeFrame: Day 1, Day 28
Secondary outcomes:
measure: Incidence of all adverse events (AEs)
timeFrame: Up to 77 days
measure: Severity of all AEs
timeFrame: Up to 77 days
measure: Outcome of all AEs
timeFrame: Up to 77 days
measure: Incidence of all serious adverse events (SAEs)
timeFrame: Up to 77 days
measure: Severity of all SAEs
timeFrame: Up to 77 days
measure: Outcome of all SAEs
timeFrame: Up to 77 days
measure: Severity of all AEs regardless of seriousness criteria
timeFrame: Up to 77 days
measure: Investigator causality assessment of all AEs regardless of seriousness criteria
timeFrame: Up to 77 days
measure: Outcomes of all AEs regardless of seriousness criteria
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in ECG parameters: QRS interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in ECG parameters: QT interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in ECG parameters: QTcF interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in continuous cardiac monitoring data
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in vital signs: Body temperature
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in vital signs: Heart rate
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 77 days
measure: Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
timeFrame: Up to 77 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials Global
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: