A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT-BLIND, MULTIPLE-DOSE, PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO5545965 IN PATIENTS WITH SCHIZOPHRENIA ON RISPERIDONE.

Hoffmann-La Roche0 sites32 target enrollmentJanuary 2014

ConditionsSchizophrenia

InterventionsPlacebo risperidone RO5545965

DrugsRO5545965 risperidone

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Schizophrenia
Sponsor: Hoffmann-La Roche
Enrollment: 32
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to psychiatrically stable patients with schizophrenia receiving risperidone.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

August 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females aged \>/= 18 years and \</= 60 years
•Clinically stable, mild or moderate schizophrenia
•On stable antipsychotic treatment for the last 6 months
•Generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
•Willingness to be hospitalized for approximately 3 weeks
•BMI \> 18.5 kg/m2 and \< 38 kg/m2
•Use of highly effective contraception as defined by the study protocol. Men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding

Exclusion Criteria

•Treatment with antiparkinson medication including anticholinergic drugs
•Treatment with depot antipsychotic medication within the last three months prior to screening
•Participation in a clinical trial with an investigational drug or device \< 3 months prior to screening
•Smokes more than 20 cigarettes per day
•Current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
•Any donation of blood or significant blood loss within three months prior to first administration of the study drug
•Use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration

Arms & Interventions

Placebo + risperidone

Intervention: Placebo

Placebo + risperidone

Intervention: risperidone

RO5545965 + risperidone

Intervention: RO5545965

RO5545965 + risperidone

Intervention: risperidone

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: Up to 10 weeks

Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs.

Time Frame: Up to 10 weeks

Secondary Outcomes

Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965(17 days)
Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone(15 days)