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 eventsHealth 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 RO5545965Pharmacokinetics: 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 = 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
Locations and Contacts
Glendale, California 91206, United States
Additional Information
Starting date: January 2014
Last updated: August 17, 2015
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