Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-0032 Phase III · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Food Effect | EXPERIMENTAL | GDC-0032 will be administered orally over 3-Treatment Period (TP) in 6-sequence as one 3 milligrams (mg) capsule in TP-A after 10 hour fasting from food, one 3 mg Phase III tablet in TP-B after 10 hour fasting from food and one 3 mg Phase III tablet in TP-C following the start of standard Food and Drug Administration (FDA) high-fat breakfast. Washout period o 14 to 20 days will be given between each TP. |
| Part 2: Tablet Formulation Comparison | EXPERIMENTAL | Different formulations of tablets (Tablet A and Tablet B) of GDC-0032 will be administered orally over 2-TP having 10 hour fasting from food. Participants will receive one 3 mg Tablet A in TP-A and one 3 mg Tablet B in TP-B after 14 to 20 days washout period. |
| Part 3: Capsule API Lot Comparison | EXPERIMENTAL | Two different lots of GDC-0032 active pharmaceutical ingredient (API) capsule formulation will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 3 mg capsule in TP-B after 14 to 20 days washout period. |
| Part 4: Tablet Relative Bioavailibity | EXPERIMENTAL | GDC-0032 will be administered orally in crossover fashion over 2-TP to 20 participants having 10 hour fasting from food. Participants will receive one 3 mg capsule in TP-A and one 2 mg Phase III tablet in TP-B after 14 to 20 days washout period. |
| Name | Type | Description |
|---|---|---|
| GDC-0032 Phase III Tablet | DRUG | Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food. |
| GDC-0032 Tablet | DRUG | Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food. |
| GDC-0032 Capsule | DRUG | Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food. |
Inclusion Criteria: * Males or females of non-childbearing potential, between 18 and 55 years of age, inclusive; females will meet the following criteria: they will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile for at least 90 days. * Body mass ...
GDC-0032 Phase III is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in clinical development to evaluate its pharmacokinetics, including the effects of particle size, formulation, and food on how the drug is processed in the body.
GDC-0032 Phase III is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule in healthy volunteer studies.
GDC-0032 Phase III is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in a completed Phase 1 trial involving healthy volunteers to assess its pharmacokinetic properties.
GDC-0032 Phase III has one completed clinical trial, NCT01980953, titled 'A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers.' This Phase 1 study enrolled 76 participants in the United States.
GDC-0032 Phase III is a designation for the drug GDC-0032, which is being studied in a Phase 1 trial. The name includes 'Phase III' but the current clinical development stage is Phase 1, as indicated by the completed trial NCT01980953.