Trials / Completed
CompletedNCT04475848
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Mental Disorders
- Neurodevelopmental Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RO6953958 | 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). |
| DRUG | Placebo | 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. |
| DRUG | Midazolam | 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. |
Timeline
- Start date
- 2020-07-15
- Primary completion
- 2022-02-06
- Completion
- 2022-02-06
- First posted
- 2020-07-17
- Last updated
- 2024-07-10
- Results posted
- 2024-07-10
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04475848. Inclusion in this directory is not an endorsement.