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 being developed by Roche Holding AG (RHHBY). It has been studied in healthy volunteers in Phase 1 clinical trials. The drug is not approved and remains in clinical development.
RO5285119 has been studied in healthy volunteers, meaning it is not yet being tested in patients with a specific disease. Its intended therapeutic use has not been established, as it is still in early-stage clinical development.
RO5285119 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche has sponsored multiple Phase 1 clinical trials of the drug in healthy volunteers.
RO5285119 is in Phase 1 clinical development. All four completed trials were Phase 1 studies, and the drug is still investigational. It has not been approved by regulatory authorities.
RO5285119 has been studied in four completed Phase 1 trials: NCT01418963, NCT01708616, NCT01967979, and NCT02179866. These trials enrolled a total of 135 healthy volunteers and were conducted in France and the Netherlands.
No, RO5285119 is not the same as risperidone. One clinical trial, NCT01708616, studied the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers, but they are distinct drugs.