Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5285119 · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| [14C]-labeled RO5285119 | EXPERIMENTAL | Single oral dose - drinking solution |
| Cohort 1 (Itraconazole DDI) | EXPERIMENTAL | - |
| Cohort 2 (Fluoxetine DDI) | EXPERIMENTAL | - |
| Placebo + risperidone | PLACEBO_COMPARATOR | - |
| Placebo +placebo | PLACEBO_COMPARATOR | - |
| RO5285119 + placebo | ACTIVE_COMPARATOR | - |
| RO5285119 + risperidone | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RO5285119 | DRUG | Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) \[14C\]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1 |
| fluoxetine | DRUG | Multiple doses |
| itraconazole | DRUG | Multiple doses |
| RO5285119 placebo | DRUG | multiple doses |
| risperidone | DRUG | single dose |
| risperidone placebo | DRUG | single dose |
| placebo | DRUG | single and multiple oral doses |
Inclusion Criteria: * Healthy male participants, 35 to 64 years of age, inclusive * For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last...
RO5285119 is an investigational small molecule developed by Roche Holding AG. It has been studied in Phase 1 clinical trials involving healthy volunteers rather than patients with a specific disease. All four of its recorded trials are completed, and no target patient population has been disclosed for the compound.
RO5285119 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 1 clinical program for the compound, including studies conducted in the Netherlands and France.
RO5285119 is in Phase 1 development. All four of its registered trials are Phase 1 studies, and all four are completed. The program enrolled 135 participants in total, and the studies were conducted in healthy volunteers.
RO5285119 has been evaluated in four completed Phase 1 trials: NCT02179866, a six-participant absorption, metabolism and excretion study in the Netherlands; NCT01967979, a 28-participant drug interaction study with itraconazole and fluoxetine; NCT01708616, a 24-participant combination study with risperidone in France; and NCT01418963, a 77-participant study in healthy volunteers.
RO5285119 trials were randomized, double-blind, and placebo-controlled, and all enrolled healthy volunteers. NCT01418963 was the largest with 77 participants, followed by NCT01967979 with 28, NCT01708616 with 24, and NCT02179866 with six. The studies took place in the Netherlands and France.