Healthy Participants
Conditions
Brief summary
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.
Interventions
DRUGBMS-986166
Specified dose on specified days
DRUGBisacodyl
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Number of participants with clinical laboratory test abnormalities | Up to 90 days |
Countries
United States
Outcome results
None listed