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Also known as GDC-0810 Phase II Tablet
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 an investigational small molecule developed by Roche Holding AG (ticker RHHBY). It has been studied in a Phase 1 clinical trial, not a Phase II trial, despite the Phase II designation in its name. The drug is not approved and remains in clinical development.
GDC-0810 Phase II has been evaluated in healthy volunteers, not in patients with a specific disease. The completed Phase 1 trial enrolled 45 healthy female volunteers aged 40 years and older in the United Kingdom. No therapeutic indication has been disclosed for this drug.
GDC-0810 Phase II is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program for this investigational small molecule.
GDC-0810 Phase II is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
GDC-0810 Phase II has been studied in one completed Phase 1 trial, NCT02722018, titled Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810. The trial enrolled 45 healthy female volunteers in the United Kingdom and used a controlled, non-double-blind design.
Yes, GDC-0810 Phase II Tablet is another name for GDC-0810 Phase II. Both refer to the same investigational small molecule developed by Roche Holding AG under ticker RHHBY. The tablet name reflects the oral tablet formulation studied in the Phase 1 pharmacokinetic trial.