Clinical Trials/NCT04965402

NCT04965402

Completed

Phase 1

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

Bristol-Myers Squibb1 site in 1 country23 target enrollmentJuly 15, 2021

ConditionsHealthy Volunteers

InterventionsBMS-986166 Placebo

DrugsBMS-986166

Overview

Phase: Phase 1
Intervention: BMS-986166
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Enrollment: 23
Locations: 1
Primary Endpoint: PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 15, 2021

End Date

February 7, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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

Arms & Interventions

Panel 1: Dose 1

Intervention: BMS-986166

Panel 2: Dose 2

Intervention: BMS-986166

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)

Time Frame: Day 1, Day 28

Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)

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: Tmax

Time Frame: Day 1, Day 28

PK parameters of BMT-121795: AUC(TAU)

Time Frame: Day 1, Day 28

PK parameters of BMT-121795: Cmax

Time Frame: Day 1, Day 28

Secondary Outcomes

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 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 ECG parameters: QRS interval(Up to 77 days)
Incidence of clinically significant changes in ECG parameters: QT interval(Up to 77 days)
Incidence of clinically significant changes in ECG parameters: QTcF interval(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 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)
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)