Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4917838 · 14 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| RO4917838 20 milligrams (mg) | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| RO4917838 10 mg | EXPERIMENTAL | Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years. |
| Placebo | PLACEBO_COMPARATOR | Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks. |
| 4 | PLACEBO_COMPARATOR | - |
| A: film coated tablets, fasted condition | EXPERIMENTAL | - |
| B: film coated tablets, fed condition | EXPERIMENTAL | - |
| C: hard gelatin capsules | EXPERIMENTAL | - |
| D: oral suspension | EXPERIMENTAL | - |
| RO4917838 + non-alcoholic drink | ACTIVE_COMPARATOR | - |
| RO4917838 + alcohol | EXPERIMENTAL | - |
| RO4917838 placebo + alcohol | PLACEBO_COMPARATOR | - |
| RO4917838 placebo + non-alcoholic drink | PLACEBO_COMPARATOR | - |
| A | ACTIVE_COMPARATOR | - |
| B | PLACEBO_COMPARATOR | - |
| C | EXPERIMENTAL | - |
| Single Arm | EXPERIMENTAL | - |
| Healthy Subjects Arm | EXPERIMENTAL | - |
| Renal Impaired Subjects Arm | EXPERIMENTAL | - |
| Healthy subjects | EXPERIMENTAL | - |
| Hepatic impairment | EXPERIMENTAL | - |
| RO4917838 | EXPERIMENTAL | - |
| Treatment A | EXPERIMENTAL | - |
| Treatment B | EXPERIMENTAL | - |
| Treatment C | PLACEBO_COMPARATOR | - |
| Treatment D | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral doses, once a day for 52 weeks |
| RO4917838 | DRUG | Oral dose level 1, once a day for 52 weeks |
| Antipshychotics (Standard of Care) | DRUG | Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56. |
| Standard antipsychotic therapy | DRUG | As prescribed |
| RO4927838 | DRUG | hard gelatin capsule, single dose |
| Placebo to RO4917838 | DRUG | Single dose of placebo to RO4917838 |
| Alcohol | OTHER | Standard alcoholic drink |
| diazepam | DRUG | Single dose |
| valproate | DRUG | Multiple doses |
| carbamazepine | DRUG | multiple oral doses, Days 1-24 of study period 2 |
| RO4917838 and Rosuvastatin | DRUG | multiple oral doses of RO4917838 and single oral dose of Rosuvastatin |
| Moxifloxacin | DRUG | Single oral dose on Day 1 |
| RO4917838 placebo | DRUG | Oral daily doses of placebo to RO4917838 for 10 days |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Diagnosis of schizophrenia * Clinical stability for 16 weeks (4 months) prior to randomization * Antipsychotic treatment stability for the past 12 weeks prior to randomization * With the exception of clozapine, patients are on any of the ...
RO4917838 is an investigational small molecule being studied for use in schizophrenia. It is currently in Phase 1 clinical development, with trials conducted in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is not yet approved and remains under investigation by its developer.
RO4917838 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting Phase 1 clinical trials to evaluate the drug's properties in healthy volunteers as part of early-stage research.
RO4917838 is in Phase 1 clinical development. All ten trials associated with the drug have been completed, with no active trials currently ongoing. The drug is investigational and has not been approved for any use.
RO4917838 has completed ten Phase 1 trials, including NCT01356550, NCT01433575, NCT01613040, and NCT01665976. These studies evaluated the drug's pharmacokinetics in healthy volunteers, including effects of hepatic impairment, food, and QTcF interval. All trials are completed with no active studies.
RO4917838 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials, which are all completed. The drug is being studied for schizophrenia but has not yet received regulatory approval for any indication.