Healthy volunteers Not Applicable
Conditions
Interventions
Participants will receive the treatments in 2 parts
Part 1 (RO7268489): Participants will receive RO7268489 once-daily (QD), orally, for up to 28 days.
Part 1 (Placebo): Participants will receive RO72
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 - 64 years, who are overtly healthy (defined by absence of evidence of any active or chronic disease) 2. BMI within the range of 18.5 to 30 kg/m² (inclusive)
Exclusion criteria
Exclusion criteria: 1. History of malignancy in the past 5 years. 2. History of any clinically significant psychiatric disorder. 3. History of severe unpleasant experience following the use of cannabis-containing products 4. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. 5. Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility (Part 1 only). 6. Vaccination within 2 weeks prior to Day 1 including influenza and/or SARS-CoV-2/ COVID-19 vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of participants with adverse events (AEs) and severity of AEs assessed using data from electronic case reported forms (eCRF) from screening up to Day 99 Part 2: PK parameters of RO7268489 and its metabolites, measured using standard non-compartmental method from the plasma samples collected at multiple timepoints up to Day 89 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Part 1: PK parameters of RO7268489 and its metabolites, measured using standard non-compartmental methods from the plasma samples collected at multiple timepoints up to Day 99 2. Part 1: PK parameters of RO7268489 and its metabolites, measured using standard non-compartmental methods from the urine samples collected at multiple timepoints up to Day 30 3. Part 1: Concentration of RO7268489 and its metabolites in cerebrospinal fluid (CSF) measured using standard non-compartmental methods from samples collected at pre-dose and multiple timepoints post-dose up to Day 27 4. Part 1: Time course of 2-AG levels in CSF and serum measured using validated LC-MS/MS method from samples collected at pre-dose and multiple time-points post-dose up to Day 32 5. Part 1: Change from Baseline in 2- arachidonoylglycerol (2-AG) levels in CSF and serum measured using validated liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method from samples collected at pre-dose and multiple timepoints post-dose up to Day 32 6. Part 1 and 2: Change in neuropsychiatric symptom scores using the Brief Psychiatric Rating Scale (BPRS) from baseline up to follow-up (Part 1: up to Day 99, Part 2: up to Day 89) 7. Part 1 and 2: Change in suicide risk the using Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline up to follow-up (Part 1: up to Day 99, Part 2: up to Day 89) 8. Part 1 and 2: Assessment of withdrawal symptoms using the Cannabis Withdrawal Scale from baseline up to Day 54 and Day 34, respectively 9. Part 1: Change in cognition using a Neurocognitive Test Battery from screening up to follow-up (up to Day 99) 10. Part 2: Number of participants with AEs and severity of AEs determined according to data collected on eCRF from screening up to follow-up (up to Day 89) 11. Part 2: RO7268489 related change in 2-AG levels in the serum measured using validated LC-MS/MS method from samples collected at pre-dose and multiple time-points post-dose up to Day 89 12. Part 2: PK pa | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials
Outcome results
None listed