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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - BMS-986020 | Experimental | 600 mg (approximately 80 micro Curie) of [14C] BMS-986020 Single Dose for 1 Day (Day 1) orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] BMS-986020 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA) | 22 Timepoints up to Day 11 | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986020 and TRA | 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 | 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 | 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 | 22 Timepoints up to Day 11 | |
| Terminal plasma half-life (T-Half) of BMS-986020 and TRA | 22 Timepoints up to Day 11 | |
| Apparent total body clearance (CL/F) of BMS-986020 | 19 Timepoints up to Day 8 | |
| Percent of plasma BMS-986020 AUC(0-T) (%AUC(0-T)) relative to plasma TRA AUC(0-T) | 22 Timepoints up to Day 11 | |
| Percent of plasma BMS-986020 AUC(INF) (%AUC(INF)) relative to plasma TRA AUC(INF) | 22 Timepoints up to Day 11 | |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Event (AE)s collected during the study will be reviewed for potential significance and clinical importance | Upto Day 11 | |
| Clinical laboratory test results: Safety laboratory testing will be drawn at specified times | Up to Day 11 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Percent of total administered radioactivity excreted in urine (% UR) |
| 13 Timepoints up to Day 11 |
| Percent of total administered radioactivity excreted in feces (% FE) | 11 Timepoints up to Day 11 |
| Percent of total administered radioactivity recovered in urine and feces (%TOTAL) | 13 Timepoints up to Day 11 |
| Vital Signs: Blood pressure, heart rate, respiratory rate, and body temperature measurements will be assessed at specified time points | 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 | Up to Day 11 |
| Physical examinations: Physical examinations will be assessed at the time points | Up to Day 11 |