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Also known as GDC-0032 Phase III Tablet
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 developed by Roche Holding AG. Despite the Phase III wording in its name, the compound has been studied in a Phase 1 clinical trial. It is also known as GDC-0032 Phase III Tablet. No therapeutic indication has been disclosed for this asset.
GDC-0032 Phase III is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the clinical program for this small molecule asset.
GDC-0032 Phase III is in Phase 1 development. The single registered trial for this asset is a Phase 1 study, and it has been completed. The drug is investigational and is not described as approved.
GDC-0032 Phase III has been evaluated in one 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. That Phase 1 trial is completed, enrolled 76 participants, was randomized and controlled, and took place in the United States.
Yes. GDC-0032 Phase III Tablet is an alternative name for GDC-0032 Phase III, so searches for either name refer to the same Roche Holding AG small molecule asset.
GDC-0032 Phase III has been studied in healthy volunteers rather than in a disclosed patient population. Its single completed Phase 1 trial, NCT01980953, examined the effect of particle size, formulation and food on the pharmacokinetics of GDC-0032 in healthy adult participants.