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This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability, pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioavailability | Experimental |
| |
| Elimination & PK | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0032 | Drug | Single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability: Absolute bioavailability of GDC-0032 (Area under the concentration-time curve [AUC]) | Days 1 to 11 | |
| Elimination & PK: Amount of drug excreted in urine/feces over the sampling interval | Days 1 to 22 | |
| Elimination & PK: Maximum concentration (Cmax) of GDC-0032 | Days 1 to 22 | |
| Elimination & PK: Area under the concentration-time curve (AUC) | Days 1 to 22 | |
| Elimination & PK: Total radioactivity concentrations in whole blood, plasma, urine, and feces. | Days 1 to 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination & PK: Metabolite identification in plasma, urine, & feces | Days 1 to 22 | |
| Safety: Incidence of adverse events | 38 to 49 days |
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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 |
|---|---|
| C582924 | 2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide |
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| GDC-0032 |
| Drug |
Single IV dose |
|