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RO7017773 · 3 trials · 3 indications
Vineland-3 is a semi-structured interview that measures an individual's adaptive behavior across 3 domains: Communication, Socialization, and Daily Living skills. Each domain is composed of 3 subdomains. Subdomain raw score is based on item responses (3-point scale: 0=never present; 1=sometimes present; 2=usually present) and is calculated for each subdomain of the three main domains as the sum of the scores for each item within the subdomain. Raw scores of the 9 subdomains are used to derive Growth Scale Values (GSVs; range = 10-197). A conversion table for mapping raw scores to GSV scores is found in Appendix 3, Table B.2 in the Vineland-3 manual (Sparrow et al. 2016). GSV is a person-ability score used to track an individual's progress. Vineland-3 ABC Composite GSV score is calculated as the mean GSV score (summing the 9 GSV subdomain scores and dividing by 9; Vineland-3 ABC Composite GSV scores can range from 10-154). A higher score indicates better adaptive functioning.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to RO7017773 for approximately 12 weeks. |
| RO7017773 Low Dose | EXPERIMENTAL | Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks. |
| RO7017773 High Dose | EXPERIMENTAL | Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks. |
| RO7017773 | EXPERIMENTAL | Single dose of RO7017773 |
| RO7017773 and Itraconazole | EXPERIMENTAL | Single dose of RO7017773 and multiple doses of itraconazole |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive oral placebo for approximately 12 weeks. |
| RO7017773 | DRUG | Participants will receive oral RO7017773 for approximately 12 weeks. |
| Itraconazole | DRUG | Multiple doses of Itraconazole |
| [11C] Ro15-4513 | OTHER | At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer \[11C\]Ro15-4513. |
Inclusion Criteria * Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Wechsler Abbreviated Scale of Intelligence (WASI-II) \>/= 50 at screening or within the last 12 months prior to screening * ASD...
RO7017773 is an investigational small molecule being studied for Autism Spectrum Disorder (ASD). It has been evaluated in clinical trials involving participants with ASD, as well as in healthy volunteers for pharmacokinetic studies. The drug is currently in clinical development and has not been approved by regulatory authorities.
RO7017773 is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. Roche has sponsored clinical trials of RO7017773 in multiple countries, including the United States, Canada, Italy, Spain, the United Kingdom, and France.
RO7017773 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study was a 12-week placebo-controlled trial in participants aged 15-45 years with Autism Spectrum Disorder. The drug remains investigational and is not yet approved for any use.
RO7017773 has been studied in three completed clinical trials. NCT03507569 was a Phase 1 PET study in the United Kingdom. NCT03774576 was a Phase 1 drug interaction study in France. NCT04299464 was a Phase 2 efficacy and safety study in the United States, Canada, Italy, and Spain.
RO7017773 is the sole name used for this drug in clinical trial records. No alternative names have been identified in the available data. The drug is consistently referred to as RO7017773 across all completed studies.
The molecular target and mechanism of action for RO7017773 have not been disclosed in the available clinical trial information. The drug is classified as a small molecule and is being investigated for its potential effects in Autism Spectrum Disorder, but its specific biological target is not publicly detailed.