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A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Placebo (Other); RO5545965 (Drug); risperidone (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

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Incidence of adverse events

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

Secondary outcome:

Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965

Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females aged >/= 18 years and

- 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

Locations and Contacts

Glendale, California 91206, United States
Additional Information

Starting date: January 2014
Last updated: August 17, 2015

Page last updated: August 23, 2015

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