The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of \[14C\] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.
Primary purpose: Other - This study will investigate the pharmacokinetic, biotransformation, routes of elimination, and mass balance of BMS-986020 in humans. The knowledge of the routes of elimination of the drug and its metabolites is useful for evaluating the likelihood of effects of renal or hepatic impairment on the disposition of BMS-986020
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA)
Time frame: 22 Timepoints up to Day 11
Time of maximum observed plasma concentration (Tmax) of BMS-986020 and TRA
Time frame: 22 Timepoints up to Day 11
Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-986020 and TRA
Time frame: 22 Timepoints up to Day 11
Area under the concentration time curve from time zero to 168 hours postdose (AUC(0-168)) of BMS-986020 and TRA
Time frame: 19 Timepoints up to Day 8
Area under the concentration time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986020 and TRA
Time frame: 22 Timepoints up to Day 11
Terminal plasma half-life (T-Half) of BMS-986020 and TRA
Time frame: 22 Timepoints up to Day 11
Apparent total body clearance (CL/F) of BMS-986020
Time frame: 19 Timepoints up to Day 8
Percent of plasma BMS-986020 AUC(0-T) (%AUC(0-T)) relative to plasma TRA AUC(0-T)
Time frame: 22 Timepoints up to Day 11
Percent of plasma BMS-986020 AUC(INF) (%AUC(INF)) relative to plasma TRA AUC(INF)
Time frame: 22 Timepoints up to Day 11
Percent of total administered radioactivity excreted in urine (% UR)
Time frame: 13 Timepoints up to Day 11
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Percent of total administered radioactivity excreted in feces (% FE)
Time frame: 11 Timepoints up to Day 11
Percent of total administered radioactivity recovered in urine and feces (%TOTAL)
Time frame: 13 Timepoints up to Day 11
Incidence of Adverse Event (AE)s collected during the study will be reviewed for potential significance and clinical importance
Time frame: Upto Day 11
Clinical laboratory test results: Safety laboratory testing will be drawn at specified times
Time frame: Up to Day 11
Vital Signs: Blood pressure, heart rate, respiratory rate, and body temperature measurements will be assessed at specified time points
Time frame: Up to Day 11
Electrocardiogram (ECG): Regular ECG endpoints (heart rate, PR interval, QRS interval, and QT intervals corrected for heart rate) and investigator identified abnormalities will be assessed at the time points
Time frame: Up to Day 11
Physical examinations: Physical examinations will be assessed at the time points
Time frame: Up to Day 11