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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5285119 placebo; Drug: risperidone; Drug: risperidone placebo; Drug: RO5285119

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + risperidone	Drug: RO5285119 placebo; multiple doses; Drug: risperidone; single dose
Placebo Comparator: Placebo +placebo	Drug: RO5285119 placebo; multiple doses; Drug: risperidone placebo; single dose
Active Comparator: RO5285119 + placebo	Drug: risperidone placebo; single dose; Drug: RO5285119; multiple doses
Experimental: RO5285119 + risperidone	Drug: risperidone; single dose; Drug: RO5285119; multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax)	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)	Pre-dose to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
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: Maximum plasma concentration (Cmax)	Day 1 to Day 18
Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC)	Day1 to Day 18

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 17, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: BP28318; 2012-003231-31 (EudraCT Number)