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
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jul 2021
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedMarch 9, 2022
February 1, 2022
7 months
July 7, 2021
February 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (34)
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
- +29 more secondary outcomes
Study Arms (3)
Panel 1: Dose 1
EXPERIMENTALPanel 2: Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Coast Clinical Trials Global
Cypress, California, 90630, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2021
First Posted
July 16, 2021
Study Start
July 15, 2021
Primary Completion
February 7, 2022
Study Completion
February 7, 2022
Last Updated
March 9, 2022
Record last verified: 2022-02