Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
| |
| Part 3: Group A | Experimental |
| |
| Part 3: Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0980 | Drug | Oral tablet dose |
| |
| GDC-0980 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration | Up to day 10 | |
| Time to maximum observed plasma concentration | Up to day 10 | |
| Plasma half-life | Up to day 10 | |
| Oral clearance | Up to day 10 | |
| Volume of distribution | Up to day 10 | |
| Minimum plasma concentration | Up to day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to day 68 | |
| Nature of adverse events | Up to day 68 | |
| Severity of adverse events |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral capsule dose |
|
| GDC-0980 | Drug | Oral tablet dose in fed state |
|
| GDC-0980 | Drug | Oral repeating dose in fasting state |
|
| GDC-0980 | Drug | Oral repeating dose in fed state |
|
| GDC-0980 | Drug | Oral tablet in a fasting state |
|
| rabeprazole | Drug | Oral repeating dose |
|
| Up to day 68 |
| 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 |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided