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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 developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to assess its safety, tolerability, and pharmacokinetics. The specific disease or condition it is intended to treat has not been disclosed.
GDC-0310 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 1 study of the compound in healthy volunteers.
GDC-0310 is in Phase 1 development. Its only recorded clinical trial, NCT02742779, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA.
GDC-0310 has been evaluated in one clinical trial, NCT02742779, titled A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers. The Phase 1 trial was completed, enrolled 95 participants, and was conducted in the United States.
The NCT02742779 trial of GDC-0310 was a randomized, double-blind, placebo-controlled Phase 1 study. It enrolled 95 healthy volunteers aged 18 years and older of all sexes across sites in the United States. The study assessed safety, tolerability, and pharmacokinetics and has been completed.