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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 being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to determine the bioavailability of various formulations of GDC-0134 in healthy female participants of non-childbearing potential. The study is completed.
GDC-0134 F09 Formulation is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 clinical trial to assess the bioavailability of different formulations of GDC-0134 in healthy volunteers.
GDC-0134 F09 Formulation is in Phase 1 clinical development. It is an investigational drug and is not approved. The single Phase 1 trial, NCT03807739, has been completed.
GDC-0134 F09 Formulation has one completed 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 trial enrolled 38 participants in the United States.
GDC-0134 F09 Formulation is a specific formulation of GDC-0134. The clinical trial NCT03807739 was designed to determine the bioavailability of various formulations of GDC-0134, including the F09 formulation, in healthy volunteers.