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This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover sequence 1 | Experimental |
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| Crossover sequence 2 | Experimental |
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| Crossover sequence 3 | Experimental |
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| Crossover sequence 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0941 | Drug | Single dose market image tablet of hardness 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) of plasma GDC-0941 | 25 Days | |
| Maximum plasma concentration (Cmax) of GDC-0941 | 25 Days | |
| Relative bioavailability (Frel) according to the model independent approach | 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 25 days | |
| Electrocardiogram (ECG) | 25 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | 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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| GDC-0941 | Drug | Single dose market image tablet of hardness 2 |
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| GDC-0941 | Drug | Single dose market image tablet of hardness 3 |
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| GDC-0941 | Drug | Single dose Phase 2 tablet formulation |
|