A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2022
Shorter than P25 for phase_1
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
September 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
September 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2023
CompletedJune 22, 2023
June 1, 2023
6 months
September 15, 2022
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of participants with serious adverse events (SAEs)
Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Up to 7 weeks
Number of deaths
Up to 7 weeks
Number of participants with AEs
Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Up to 7 weeks
Number of participants with vital sign abnormalities
Up to 7 weeks
Number of participants with physical examination abnormalities
Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Up to 7 weeks
Secondary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax)
Day 1 and Day 14
Area under the concentration-time curve within a dosing interval (AUC[TAU])
Day 1 and Day 14
Study Arms (3)
Cohort J1
EXPERIMENTALCohort J2
EXPERIMENTALCohort J3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Participant must be of Japanese descent (both biological parents are ethnically Japanese).
- In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
- Women should be of non-childbearing potential.
You may not qualify if:
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
- Any major surgery within 90 days of study drug administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anaheim Clinical Trials Llc
Anaheim, California, 92801, 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2022
First Posted
September 19, 2022
Study Start
September 28, 2022
Primary Completion
April 7, 2023
Study Completion
April 7, 2023
Last Updated
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.