ISRCTN10681798Active, not recruitingPhase 1
A phase I randomized, investigator and participant blind, adaptive, multiple-ascending dose, parallel and four-way crossover, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and drug interactions (with midazolam) of RO7308480 following oral administration in healthy participants
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Participants who are overtly healthy (defined by absence of evidence of any active
- •or chronic disease).
- •2. Body mass index (BMI) of 18.5 to 30 kilogram metered square (kg/m²) inclusive.
- •3. Affiliated with a social security scheme.
Exclusion Criteria
- •1. Any condition or disease detected during the medical interview/physical examination that could relapse during or immediately after the study, or would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study, as determined by the Investigator.
- •2. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. This includes a surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract.
- •3. Use of any psychoactive medication, or medications known to have effects on central nervous system (CNS), or blood flow taken within 4 weeks prior to dosing with RO7308480.
- •4. Use of any psychoactive medication, or medications known to have effects on CNS or blood flow taken within 4 weeks (or within 5 × the elimination half-life of the medication, whichever is longer) prior to dosing with RO7308480.
- •5. History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g., meningitis).
- •6. Part 2 only: abnormalities in the brain known at time of screening which would adversely affect the MRI data analysis.
- •7. Part 2 only: any condition or disease detected during the medical interview/physical examination which are contraindications for lorazepam such as acute narrow-angle glaucoma, hypersensitivity to benzodiazepines or to any of the other ingredients, acute pulmonary insufficiency: respiratory depression; sleep apnea (risk of further respiratory depression), obsessional states (inadequate evidence of safety and efficacy), severe hepatic insufficiency (may precipitate encephalopathy) and/or myasthenia gravis.
- •8. Participation in an investigational drug or device study within 90 days (or within 5 times the elimination half-life of the investigational drug, whichever is longer) prior to screening, as calculated from the day of follow-up from the previous study, or more than 4 times per year.
- •9. Dietary restrictions that would prohibit the consumption of standardized meals.
- •10. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that contraindicates the participation in the study.
- •11. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or total bilirubin outside of normal range (with the exception of Gilbert’s syndrome with total bilirubin < 2.5 x upper limits of normal (ULN)).
- •12. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome with total bilirubin < 2.5 x ULN).
- •13. History of suicidal behavior or any risk of suicidal behavior in the opinion of a certified clinician or as evidenced by a yes” to questions 4 and/or 5 of columbia-suicide severity rating scale (C-SSRS) taken at screening.
- •14. Coffee (including caffeinated soft drinks or tea) consumption > 5 cups per day or methylxanthine (e.g., Coca-Cola) containing drinks > 1 liter/day or > 250 grams/day of chocolate.
- •15. Participants under judicial supervision, guardianship, or curatorship.
- •16. Part 2 only: any con
Investigators
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