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This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of [14C]-GDC-0980 administered as a 10-mg oral dose to 6 healthy postmenopausal and/or surgically sterile female subjects following at least a 10-hour fast from food (not including water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | [14C]-GDC-0980 administered as a 10-mg oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-GDC-0980 | Drug | 100 uCi of [14C]-GDC-0980 in total dose of 10 mg GDC-0980 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: maximum observed concentration (Cmax) | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: time to maximum concentration (tmax) | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t) | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: area under the concentration-time curve extrapolated to infinity | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal elimination half-life (t1/2) | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent terminal phase elimination rate constant | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent total clearance | up to approximately 5 weeks | |
| Pharmacokinetic based on the plasma concentrations of total radioactivity and GDC-0980: apparent volume of distribution | up to approximately 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic based on the urine radioactivity concentrations: amount of drug excreted in the urine over sampling interval | up to approximately 5 weeks | |
| Pharmacokinetic based on the urine radioactivity concentrations: renal clearance | up to approximately 5 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 | 53704-2523 | United States |
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| Pharmacokinetic based on the urine radioactivity concentrations: percent excreted in urine | up to approximately 5 weeks |
| Pharmacokinetic parameters for the metabolites of [14C]-GDC-0980 calculated based on plasma, urine, and fecal concentration levels. | up to approximately 5 weeks |