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This will be an open-label, fixed-sequence, single-center, 2 period study. The study is designed to determine the effect of ketoconazole on the pharmacokinetics of GDC-0980.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0980 | Drug | Single oral dose |
| |
| Ketoconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: maximum observed plasma concentration | Up to approximately 10 days | |
| Pharmacokinetics: time to reach maximum observed plasma concentration | Up to approximately 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to approximately 40 days | |
| Clinical laboratory test results (hematology and serum chemistry) | Up to approximately 10 days | |
| Vital sign measurements (sitting systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature) |
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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 |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C569670 | 1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Repeating Oral Dose |
|
| Up to approximately 8 days |