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This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDC-0973 Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0973 | Drug | Single oral dose of [14C]-GDC-0973 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Route of elimination of [14C]-GDC-0973 | approximately 8 weeks | |
| Pharmacokinetics: maximum observed concentration (Cmax) | approximately 8 weeks | |
| Pharmacokinetics: time to maximum concentration (tmax) | approximately 8 weeks | |
| Pharmacokinetics: area under the concentration-time curve | approximately 8 weeks | |
| Pharmacokinetics: apparent terminal elimination phase rate constant | approximately 8 weeks | |
| Pharmacokinetics: apparent terminal elimination phase half-life | approximately 8 weeks | |
| Pharmacokinetics: apparent total clearance | approximately 8 weeks | |
| Pharmacokinetics: apparent volume of distribution | approximately 8 weeks | |
| Pharmacokinetics: amount total radioactivity in whole blood/urine/feces | approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: quantification of GDC-0973-related metabolites in plasma, urine and fecal homogenates | approximately 8 weeks | |
| Pharmacokinetics: plasma concentration of GDC-0973 | approximately 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C574276 | cobimetinib |
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| Safety: incidence of adverse events | approximately 8 weeks |