A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
- Registration Number
- NCT05409157
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group 1: BMS-986166 BMS-986166 - Treatment Group 1: BMS-986166 Bisacodyl -
- Primary Outcome Measures
Name Time Method 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 feces (%FR) Up to 90 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 Percent of TRA recovered in urine (%UR) 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
- Secondary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to 89 days Number of participants with clinical laboratory test abnormalities Up to 90 days 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 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
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Madison, Wisconsin, United States