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The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C] CC-99677.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-99677 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-99677 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of the drug (Cmax) for CC-99677 | Up to 15 days | |
| Time of maximum observed plasma concentration (Tmax) for CC-99677 | Up to 15 days | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677 | Up to 15 days | |
| Total radioactivity recovered in urine (UR) | Up to 15 days | |
| Percent of total radioactivity recovered in urine (%UR) | Up to 15 days | |
| Total radioactivity recovered in feces (FR) | Up to 15 days | |
| Percent of total radioactivity recovered in feces (%FR) | Up to 15 days | |
| Total radioactivity recovered in bile (BR) | Up to 15 days | |
| Total radioactivity recovered in urine, feces, and bile combined (Rtotal) | Up to 15 days | |
| Percent of total radioactivity recovered in all excreta (%Total) | Up to 15 days | |
| Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 50 days | |
| Incidence of serious adverse events (SAEs) | Up to 50 days | |
| Incidence of AEs leading to discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Madison | Wisconsin | 53704-2526 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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| Up to 15 days |
| Up to 15 days |
| Incidence of vital sign abnormalities | Up to 15 days |
| Incidence of electrocardiogram (ECG) abnormalities | Up to 15 days |
| Incidence of physical examination abnormalities | Up to 15 days |
| Incidence of clinical laboratory test abnormalities | Up to 15 days |
| Cmax | Up to 15 days |
| Tmax | Up to 15 days |
| AUC(0-T) | Up to 15 days |