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GDC-0310 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| High-Fat Meal SD Cohort: PIC (Part 1) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| High-Fat Meal SD Cohort: Solution Formulation (Part 3) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a high-fat meal after a 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 3. |
| Low-Fat Meal SD Cohort: PIC (Part 1) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using PIC on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| Low-Fat Meal SD Cohort: Solution Formulation (Part 3) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose given orally using PIC based on PK results from earlier SD cohorts up to an established dose yielding at least a 2-fold exposure margin to the MTD administered orally following a low-fat meal after an 8-hour/overnight fast using solution on Day 1 of the treatment period (5 days) in an additional cohort of Part 1. |
| MD Cohort: PIC (Part 2) | EXPERIMENTAL | Participants will receive multiple ascending dose administered orally using PIC from Day 1 to Day 13 twice daily (BID) or may even be thrice daily (TID) or four times a day (QD) depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. |
| MD Cohort: Solution Formulation (Part 4) | EXPERIMENTAL | Participants will receive multiple ascending dose in fed or fast condition, administered orally using solution from Day 1 to Day 13 BID or may even be TID or QD depending on clinical PK, followed by morning dose on Day 14 in 7 cohorts of Part 2. |
| Placebo PIC | PLACEBO_COMPARATOR | Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. |
| Placebo Solution | PLACEBO_COMPARATOR | Participants will receive placebo matched to GDC-0310 single or multiple ascending dose administered orally in the fasted (SD cohorts) or fed state using PIC on Day 1 of the treatment period (5 days) to the SD cohorts and from Day 1 to 14 BID or may even be TID or QD depending on clinical PK, to the MD cohorts. |
| SD Cohort: PIC (Part 1) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using PIC on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 1. |
| SD Cohort: Solution Formulation (Part 3) | EXPERIMENTAL | Participants will receive GDC-0310 single ascending dose administered orally in the fasted state using solution formulation on Day 1 of the treatment period (5 days) in the 9 cohorts of Part 3. |
| Name | Type | Description |
|---|---|---|
| GDC-0310 | DRUG | Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state. |
| Placebo | DRUG | Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state. |
Inclusion Criteria: * Female participants of non-childbearing potential must meet the criteria defined in the protocol * Body mass index within the range of 18.0 to 30.0 kilograms per meter square (kg/m\^2), inclusive, and a minimum weight of 50.0 kg Exclusion Criteria: * Have a clinically signif...
GDC-0310 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development to evaluate its safety, tolerability, and pharmacokinetics. The drug is not approved for any indication and remains in early-stage clinical testing.
GDC-0310 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 the United States.
GDC-0310 is in Phase 1 clinical development. A Phase 1 study in healthy volunteers has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.
GDC-0310 has one completed Phase 1 clinical trial, identified as NCT02742779. This study evaluated the safety, tolerability, and pharmacokinetics of GDC-0310 in 95 healthy volunteers in the United States. The trial was randomized, double-blind, and placebo-controlled.
GDC-0310 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. The drug is still in clinical development and has not been authorized for any medical use.