Rennes, 35042, France
NCT Number: NCT01708616
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
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).
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO5285119
Drugmultiple doses
RO5285119 placebo
Drugmultiple doses
Risperidone
Drugsingle dose
risperidone placebo
Drugsingle dose
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
Time frame: approximately 12 weeks
-
Pharmacodynamic markers for risperidone: Prolactin levels
Time frame: Pre-dose to 6 hours post-dose
-
Pharmacodynamic assessments for risperidone: Level of sedation
Time frame: Pre-dose to 24 hours post-dose
-
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 18
-
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
Time frame: Day1 to Day 18
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Oct 17, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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