Healthy Volunteer
Conditions
Brief summary
This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).
Interventions
DRUGRO5285119
multiple doses
DRUGRO5285119 placebo
multiple doses
DRUGrisperidone
single dose
DRUGrisperidone placebo
single dose
Sponsors
Hoffmann-La Roche
Study design
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis * Body mass index (BMI) 18 to 30 kg/m2 inclusive * Women have to be postmenopausal or surgically sterile * Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing
Exclusion criteria
* Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse * Positive for hepatitis B, hepatitis C or HIV infection * History of clinically significant hypersensitivity or allergic reactions * Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson * Regular smoker (\>5 cigarettes, \>3 pipe-fulls, \>3 cigars per day) * Administration of an investigational drug or device within 3 months prior to first dosing * Hypersensitivity to risperidone or any of its excipients * Any other known contraindications to risperidone as stated in the SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax) | Pre-dose to 24 hours post-dose |
| Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC) | Pre-dose to 24 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic assessments for risperidone: Level of sedation | Pre-dose to 24 hours post-dose |
| Safety: Incidence of adverse events | approximately 12 weeks |
| Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC) | Day1 to Day 18 |
| Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax) | Day 1 to Day 18 |
| Pharmacodynamic markers for risperidone: Prolactin levels | Pre-dose to 6 hours post-dose |
Countries
France
Outcome results
None listed