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Also known as Basmisanil
RO5186582 · 2 trials · 2 indications
The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite T-score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher composite T-score represents lower impairment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received matching Placebo to Basmisanil orally twice daily for 24 weeks. |
| Basmisanil 80mg BID | EXPERIMENTAL | Participants received Basmisanil 80 mg orally twice daily (BID) for 24 weeks. |
| Basmisanil 240mg BID | EXPERIMENTAL | Participants received Basmisanil 240 mg orally twice daily (BID) for 24 weeks. |
| IV Midazolam Alone | OTHER | A single 1 milligram (mg) dose of IV Midazolam on Day 1. |
| Oral Midazolam Alone | OTHER | A single 5 mg oral dose of midazolam on Day 2. |
| RO5186582 Alone | EXPERIMENTAL | RO5186582 240 mg oral tablet twice daily (BID) for 14 days from Days 3 to 16. |
| RO5186582 Plus IV Midazolam | EXPERIMENTAL | RO5186582 240 mg BID oral tablet in combination with a single 1 mg IV dose of midazolam on Day 17. |
| RO5186582 Plus Oral Midazolam | EXPERIMENTAL | RO5186582 240 mg BID in combination with a single 5 mg oral dose of midazolam on Day 18. |
| Name | Type | Description |
|---|---|---|
| Basmisanil | DRUG | Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above. |
| Placebo | DRUG | Participants received matching Placebo to Basmisanil, as per the dosing schedules described above. |
| Midazolam, IV | DRUG | 2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min). |
| Midazolam, oral | DRUG | 0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam. |
| RO5186582 | DRUG | RO5186582 120 mg film-coated release tablet. |
Inclusion Criteria: * Diagnosis of schizophrenia of any type utilizing the Mini International Neuropsychiatric Interview and diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) direct clinical assessments, family informants and past medical records * Evidence of stability o...
RO5186582 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial involving healthy volunteers, and no therapeutic indication has been disclosed for the compound. It is not described as an approved medicine.
RO5186582 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the clinical work conducted on the compound, including the Phase 1 study listed on ClinicalTrials.gov.
RO5186582 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no later-stage trials are recorded. The compound remains investigational and has not been described as approved by the FDA or any other regulator.
RO5186582 has been evaluated in a single Phase 1 study, NCT02254759, titled A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants. That trial enrolled 12 healthy volunteers in the United Kingdom, used a controlled design, and has been completed.
The completed Phase 1 trial NCT02254759 examined the effect of RO5186582 treatment on cytochrome P450 3A4 activity in healthy participants. It enrolled 12 healthy volunteers aged 18 years and older in the United Kingdom and was a controlled study that has since finished.