CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 88 enrolled
Drug / intervention
RO6953958 +2 moredrug
Likely dose
RO6953958 5 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04475848
NCT04475848Phase 1Completed
CompareCT.gov

A Randomized, Investigator- /Subject-blind, Single- and Multiple-ascending Dose, Placebo-controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 (Including RO6953958 Effect on Midazolam) Following Oral Administration in Healthy Male Participants

Hoffmann-La Roche·interventional·Posted Jul 17, 2020·Updated Jul 10, 2024

In Brief

A Phase 1 clinical trial evaluating RO6953958, Placebo, and 1 other intervention for Autistic Disorder and 4 related conditions. Completed, enrolled 88 participants across 1 site.

Detailed Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral administration in healthy male participants. Part 3 (Drug-drug interaction (DDI)) will assess the safety, tolerability, and effect of RO6953958 on the PK of the cytochrome P450 (CYP) 3A substrate midazolam.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders, Neurodevelopmental Disorders
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 17, 2020
Enrollment StartJul 15, 2020
Primary CompletionFeb 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.0 years ago

Interventions

RO6953958drug

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).

Placebodrug

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.

Midazolamdrug

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.