A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

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

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).

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 events

Pharmacodynamic 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)

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

Rennes 35042, France

Starting date: November 2012
Last updated: August 17, 2015