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GDC-0810 Phase II · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: GDC-0810 dose level A - Low Fat Meal | EXPERIMENTAL | Participants will receive a single dose of GDC-0810 dose level A on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal in the form of Phase II tablet or one of three Phase III prototype tablets (Prototype 1, 2 or 3) in a crossover fashion. |
| Part 2 (Optional): GDC-0810 dose level A - Low Fat Meal | EXPERIMENTAL | Participants will receive a single dose of GDC-0810 dose level A on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal in the form of Phase II tablet or one of two Phase III prototype tablets (Prototype 4 or 5) in a crossover fashion. |
| Part 3: GDC-0810 dose level B - Low Fat Meal/Fasted | EXPERIMENTAL | Participants will receive a single dose of GDC-0810 dose level B on Day 1 of each treatment period. GDC-0810 will be administered with low fat meal or under fasted condition either as Phase II tablet (with low fat meal) or as the Phase III prototype tablet selected from Parts 1 or 2 (with low fat meal or under fasted conditions), in a crossover fashion. |
| Name | Type | Description |
|---|---|---|
| GDC-0810 Phase II Tablet | DRUG | Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets. |
| GDC-0810 Phase III Prototype Tablet | DRUG | Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets. |
Inclusion Criteria: * Female participants of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure * Body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive * In good hea...
GDC-0810 Phase II is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, not Phase 2, and is being investigated for its pharmacokinetic properties, including the effect of formulation and food on its absorption. The drug is not approved and remains investigational.
GDC-0810 Phase II is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers. Roche is the sole developer listed for this asset.
GDC-0810 Phase II is in Phase 1 clinical development, despite its name suggesting a later stage. It is an investigational small molecule being studied in healthy volunteers. The drug has not been approved by regulatory authorities and is still undergoing clinical trials.
GDC-0810 Phase II is associated with one completed clinical trial, NCT02722018, titled 'Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810.' This Phase 1 study enrolled 45 healthy female volunteers in the United Kingdom and was controlled but not double-blinded.
GDC-0810 Phase II appears to be a designation for the drug GDC-0810, which is being studied in a Phase 1 trial. The name 'Phase II' may refer to a specific formulation or study stage, but the active ingredient is GDC-0810. No alternative names are provided for this asset.