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Also known as [14C]-GDC-0810, ARN-810
GDC-0810 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Female Healthy Volunteers | EXPERIMENTAL | Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7. |
| Name | Type | Description |
|---|---|---|
| GDC-0810 | DRUG | During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive). |
| Pravastatin | DRUG | Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2. |
Inclusion Criteria: * Female subjects between 18 and 65 years of age, inclusive. * Female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure. * Within BMI range 18.5 to \</= 29.9 kg/m\^2, ...
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GDC-0810 is an investigational small molecule being developed by Roche Holding AG (ticker RHHBY) for breast cancer. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. It is not described as approved, so it remains an investigational agent.
GDC-0810 is being developed for breast cancer. The only listed clinical trial involving GDC-0810 enrolled healthy female subjects of non-childbearing potential and evaluated the effect of GDC-0810 on the pharmacokinetics of pravastatin. The trial was conducted in the United States and has been completed.
GDC-0810 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor associated with the clinical development of this investigational small molecule for breast cancer.
GDC-0810 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials listed. The completed trial enrolled 15 participants and was an uncontrolled study without randomization or double blinding.
GDC-0810 has been studied in one completed Phase 1 trial, NCT02621957, titled Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential. It enrolled 15 healthy female volunteers in the United States and is listed as completed.
Yes, [14C]-GDC-0810 is an alternative name for GDC-0810. Both names refer to the same investigational small molecule developed by Roche Holding AG for breast cancer, so searches using either name point to the same asset.