A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: RO5285119 (Drug); RO5285119 placebo (Drug); risperidone (Drug); risperidone placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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).
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)
Secondary outcome: Safety: Incidence of adverse eventsPharmacodynamic markers for risperidone: Prolactin levels Pharmacodynamic assessments for risperidone: Level of sedation Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax) Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Rennes 35042, France
Additional Information
Starting date: November 2012
Last updated: August 17, 2015
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