Clinical trial NCT01708616: A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER

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).


Eligibility 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

Primary outcomes:
measure: Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)
timeFrame: Pre-dose to 24 hours post-dose
measure: Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose to 24 hours post-dose
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 12 weeks
measure: Pharmacodynamic markers for risperidone: Prolactin levels
timeFrame: Pre-dose to 6 hours post-dose
measure: Pharmacodynamic assessments for risperidone: Level of sedation
timeFrame: Pre-dose to 24 hours post-dose
measure: Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax)
timeFrame: Day 1 to Day 18
measure: Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)
timeFrame: Day1 to Day 18
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: