A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
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 Apr 2023
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
April 3, 2023
CompletedStudy Start
First participant enrolled
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedNovember 7, 2023
October 1, 2023
6 months
April 3, 2023
November 3, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Number of participants with Adverse events
Up to day 92
Number of participants with clinical laboratory abnormalities
Up to day 64
Number of participants with vital sign abnormalities
Up to day 64
Number of participants with ECG abnormalities
Up to day 64
Number of participants with physical examination abnormalities
Up to day 64
Secondary Outcomes (7)
Serum concentrations of BMS-986325
Up to day 64
Maximum observed serum concentration (Cmax)
Up to day 64
Time of maximum observed serum concentration (Tmax)
Up to day 64
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to day 64
Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation
Up to day 64
- +2 more secondary outcomes
Study Arms (3)
Cohort J1
EXPERIMENTALCohort J2
EXPERIMENTALCohort J3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
- Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.
You may not qualify if:
- Any significant acute or chronic medical illness.
- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Cypress, California, 90630, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 14, 2023
Study Start
April 10, 2023
Primary Completion
October 2, 2023
Study Completion
October 2, 2023
Last Updated
November 7, 2023
Record last verified: 2023-10