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GDC-0134 F09 Formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part I: GDC-0134 F16 vs F09 Capsule Formulation | EXPERIMENTAL | In Part 1 participants will receive single doses of either GDC-0134 F16 capsules (prototype) or GDC-0134 F09 capsules (reference) after having consumed a standard meal. |
| Part II: GDC-0134 F15 vs F09 Capsule Formulation | EXPERIMENTAL | In Part 2, participants will receive a single dose of either GDC-0134 F15 capsules (prototype) or GDC-0134 F09 capsules (reference) after an overnight fast. |
| Name | Type | Description |
|---|---|---|
| GDC-0134 F09 Formulation | DRUG | Participants will receive a single oral dose of GDC-0134 reference capsule F09. |
| GDC-0134 F15 Formulation | DRUG | Participants will receive a single oral dose of GDC-0134 prototype capsule F15. |
| GDC-0134 F16 Formulation | DRUG | Participants will receive a single oral dose of GDC-0134 prototype capsule F16. |
Inclusion Criteria * Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2) * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs; * Clinical laboratory evaluations within the reference range fo...
GDC-0134 F09 Formulation is an investigational small molecule developed by Roche Holding AG. It is a specific formulation of GDC-0134 that was studied in a Phase 1 clinical trial to evaluate its bioavailability in healthy female participants. The drug's therapeutic indication has not been disclosed.
GDC-0134 F09 Formulation is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this formulation.
GDC-0134 F09 Formulation is in Phase 1 development. It has been evaluated in one completed Phase 1 clinical trial and is not currently in any active trials. It is an investigational agent and has not been approved by the FDA.
GDC-0134 F09 Formulation was studied in one clinical trial, NCT03807739, titled A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential. The Phase 1 trial was completed, enrolled 38 participants, was randomized and controlled, and took place in the United States.
GDC-0134 F09 Formulation was studied in healthy female volunteers of non-childbearing potential, not in a patient population with a specific disease. The trial's purpose was to determine the bioavailability of various formulations of GDC-0134. No therapeutic indication for this drug has been disclosed.