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RO6953958 · 1 trial · 5 indications
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
The C-SSRS is a questionnaire that is used to assess a participant's suicidal ideation and behaviors. The categories in the questionnaire have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present. Categories with non-zero values are reported here.
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD/FE | EXPERIMENTAL | There will be 7 cohorts in this study. In each cohort, participants will receive a single oral dose of RO6953958 while fasted. Participants in the fed (FE) cohort will return to receive the same single oral dose of RO6953958 repeated in the fed state. |
| Part 1: SAD placebo | PLACEBO_COMPARATOR | There will be 7 cohorts in this study. In each cohort, participants will receive a single oral dose of a placebo while fasted/fed. |
| Part 2: MAD | EXPERIMENTAL | A maximum of 5 dose levels are anticipated. For each dose level, a minimum of 8 and a maximum of 16 participants will receive a multiple oral dose of RO6953958 once daily (QD) for 10 days. |
| Part 2: MAD placebo | PLACEBO_COMPARATOR | A maximum of 5 dose levels are anticipated. For each dose level, a minimum of 8 and a maximum of 16 participants will receive a multiple oral dose of palcebo QD for 10 days. |
| Part 3: DDI | EXPERIMENTAL | RO6953958 will be administered at the maximum dose QD that was tested in the ongoing Part 2 (MAD). Participants will also be administered midazolam. |
| Name | Type | Description |
|---|---|---|
| RO6953958 | DRUG | Part 1: RO6953958 will be administered in an adaptive manner. The starting dose is planned to be 5 milligrams (mg). Part 2: The starting dose is planned to be 45 mg. Part 3: RO6953958 will be administered QD following a standardized breakfast on Day 3 to Day 14 at the maximum dose QD that was tested in the ongoing Part 2 (MAD). |
| Placebo | DRUG | Part 1: A placebo will be administered in an adaptive manner. The starting dose is planned to be 5 mg. Part 2: The starting dose is planned to be 45 mg. |
| Midazolam | DRUG | Midazolam will be administered as single intervenous (IV) bolus injection of 100 micrograms (ug) on Day 1 and Day 13, and as single oral dose of 300 ug on Day 2 and Day 14. |
Inclusion Criteria: * Body mass index (BMI) within 18 to 31 kg/m2 * During treatment and for at least 14 days after the last dose to remain abstinent * Refrain from donating sperm for at least 14 days after last dose * Part 2 (MAD) only - Participants must be prepared to collect a sleep log and wea...
RO6953958 is an investigational small molecule being studied for Autistic Disorder and Autism Spectrum Disorder. It is in Phase 1 clinical development by Roche Holding AG. The drug is intended for psychiatric use, targeting conditions related to neurodevelopmental disorders.
RO6953958 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for the treatment of autistic disorder and autism spectrum disorder.
RO6953958 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
RO6953958 has one completed Phase 1 clinical trial, identified as NCT04475848. This study investigated the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of RO6953958 in healthy male participants aged 18 years and older. The trial was conducted in the United Kingdom and enrolled 88 participants.
RO6953958 is the primary name for this investigational compound. No alternative names have been established for this drug in clinical development. It is being studied under this identifier in the completed Phase 1 trial.