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This will be a single-center, open-label, randomized, 2-part study to determine the relative bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | Oral repeating dose |
| |
| GDC-0941 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, nature, and severity of adverse events | Through study completion or early study discontinuation | |
| Pharmacokinetic parameters of GDC-0941 (total exposure, maximum and minimum plasma concentration) | Prior to and after GDC-0941 dosing |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site | Austin | Texas | 78744 | United States |
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| Drug |
Oral repeating dose |
|
| ketoconazole | Drug | Oral repeating dose |
|
| ID | Term |
|---|---|
| C532162 | 2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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