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This study will be an open-label, non-randomized, absorption, metabolism, and excretion study of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least a 10-hour fast from food (not including water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | Single oral dose\n \n\n\n\n |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal elimination half-life | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent terminal phase elimination rate constant | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent total clearance | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: apparent volume of distribution | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve extrapolated to infinity | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: area under the concentration-time curve from Hour 0 to the last measurable concentration | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: maximum observed concentration | up to approximately 6 weeks or early study discontinuation | |
| Pharmacokinetic property based on the plasma concentrations of total radioactivity and GDC-0941: time to maximum concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of drug excreted in the feces over the sampling interval | up to approximately 6 weeks or early study discontinuation | |
| Percent excreted in feces | up to approximately 6 weeks or early study discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Holden, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704-2523 | United States |
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| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
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| up to approximately 6 weeks or early study discontinuation |