A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants
1 other identifier
interventional
7
1 country
1
Brief Summary
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 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
June 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2022
CompletedMarch 22, 2023
March 1, 2023
4 months
June 3, 2022
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (9)
Total amount of total radioactivity (TRA) recovered in urine (UR)
Up to 90 days
Total amount of TRA recovered in feces (FR)
Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
Up to 90 days
Percent of TRA recovered in urine (%UR)
Up to 90 days
Percent of TRA recovered in feces (%FR)
Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
Up to 90 days
Maximum observed concentration (Cmax)
Up to 89 days
Time of maximum observed concentration (Tmax)
Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Up to 89 days
Secondary Outcomes (9)
Number of participants with adverse events (AEs)
Up to 124 days
Number of participants with serious adverse events (SAEs)
Up to 124 days
Number of participants with vital sign abnormalities
Up to 90 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 90 days
Number of participants with physical examination abnormalities
Up to 90 days
- +4 more secondary outcomes
Study Arms (1)
Treatment Group 1: BMS-986166
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male 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 between 18.0 to 33.0 kg/m2 (inclusive)
You may not qualify if:
- Any significant acute or chronic medical illness
- Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
- History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution - 0001
Madison, Wisconsin, 53704-2526, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2022
First Posted
June 8, 2022
Study Start
June 17, 2022
Primary Completion
October 15, 2022
Study Completion
October 15, 2022
Last Updated
March 22, 2023
Record last verified: 2023-03