A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 24
- Primary Endpoint
- Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Intervention Model
- Crossover
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo +placebo
Intervention: RO5285119 placebo (Drug)
Placebo + risperidone
Intervention: RO5285119 placebo (Drug)
Placebo + risperidone
Intervention: risperidone (Drug)
Placebo +placebo
Intervention: risperidone placebo (Drug)
RO5285119 + placebo
Intervention: RO5285119 (Drug)
RO5285119 + placebo
Intervention: risperidone placebo (Drug)
RO5285119 + risperidone
Intervention: RO5285119 (Drug)
RO5285119 + risperidone
Intervention: risperidone (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
Time Frame: 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)
Time Frame: Pre-dose to 24 hours post-dose
Secondary Outcomes
- Safety: Incidence of adverse events(approximately 12 weeks)
- Pharmacodynamic markers for risperidone: Prolactin levels(Pre-dose to 6 hours post-dose)
- Pharmacodynamic assessments for risperidone: Level of sedation(Pre-dose to 24 hours post-dose)
- 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)