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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5285119 placebo; Drug: RO5285119; Drug: risperidone placebo; Drug: risperidone

• Registration Number: NCT01708616
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-17
• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo +placebo	risperidone placebo	-
Placebo + risperidone	RO5285119 placebo	-
Placebo +placebo	RO5285119 placebo	-
RO5285119 + placebo	RO5285119	-
RO5285119 + risperidone	RO5285119	-
RO5285119 + placebo	risperidone placebo	-
RO5285119 + risperidone	risperidone	-
Placebo + risperidone	risperidone	-

Primary Outcome Measures

Name	Time	Method
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

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