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

NCT ID: NCT01708616

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo + risperidone

Group Type PLACEBO_COMPARATOR

RO5285119 placebo

Intervention Type DRUG

multiple doses

risperidone

Intervention Type DRUG

single dose

Placebo +placebo

Group Type PLACEBO_COMPARATOR

RO5285119 placebo

Intervention Type DRUG

multiple doses

risperidone placebo

Intervention Type DRUG

single dose

RO5285119 + placebo

Group Type ACTIVE_COMPARATOR

RO5285119

Intervention Type DRUG

multiple doses

risperidone placebo

Intervention Type DRUG

single dose

RO5285119 + risperidone

Group Type EXPERIMENTAL

RO5285119

Intervention Type DRUG

multiple doses

risperidone

Intervention Type DRUG

single dose

Interventions

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RO5285119

multiple doses

Intervention Type DRUG

RO5285119 placebo

multiple doses

Intervention Type DRUG

risperidone

single dose

Intervention Type DRUG

risperidone placebo

single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2012-003231-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28318

Identifier Type: -

Identifier Source: org_study_id