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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965402
• Other study ID #: IM018-007
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2021
• Est. completion date: February 7, 2022

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986166
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	West Coast Clinical Trials Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)		Day 1, Day 28
Primary	PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)		Day 1, Day 28
Primary	PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))		Day 1, Day 28
Primary	PK parameters of BMT-121795: Cmax		Day 1, Day 28
Primary	PK parameters of BMT-121795: Tmax		Day 1, Day 28
Primary	PK parameters of BMT-121795: AUC(TAU)		Day 1, Day 28
Secondary	Incidence of all adverse events (AEs)		Up to 77 days
Secondary	Severity of all AEs		Up to 77 days
Secondary	Outcome of all AEs		Up to 77 days
Secondary	Incidence of all serious adverse events (SAEs)		Up to 77 days
Secondary	Severity of all SAEs		Up to 77 days
Secondary	Outcome of all SAEs		Up to 77 days
Secondary	Severity of all AEs regardless of seriousness criteria		Up to 77 days
Secondary	Investigator causality assessment of all AEs regardless of seriousness criteria		Up to 77 days
Secondary	Outcomes of all AEs regardless of seriousness criteria		Up to 77 days
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 77 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of clinically significant changes in ECG parameters: QTcF interval	QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)	Up to 77 days
Secondary	Incidence of clinically significant changes in continuous cardiac monitoring data		Up to 77 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 77 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 77 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 77 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 77 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 77 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 77 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in ECG parameters: QT interval		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in vital signs: Body temperature		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in vital signs: Blood pressure		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in vital signs: Heart rate		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests		Up to 77 days
Secondary	Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests		Up to 77 days

External Links

•   BMS Clinical Trial Information
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