A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: BMS-986166

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • West Coast Clinical Trials Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Experimental: Panel 1: Dose 1	Drug: BMS-986166; Specified dose on specified days
Experimental: Panel 2: Dose 2	Drug: BMS-986166; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	PR interval: The time from the onset of the P wave to the start of the QRS complex	Up to 77 days
Incidence of clinically significant changes in ECG parameters: QRS interval	QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization	Up to 77 days
Incidence of clinically significant changes in ECG parameters: QT interval	QT interval: Measured from the beginning of the QRS complex to the end of the T wave	Up to 77 days
Incidence of clinically significant changes in ECG parameters: QTcF interval	QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	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 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 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): February 7, 2022
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Japan; BMS-986166
• Other Study ID Numbers: IM018-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No