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

Schizophrenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019329
• Other study ID #: BP29188
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2013
• Last updated: November 1, 2016
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Placebo
Oral daily administration from Days 1-12

Drug:
• RO5545965
Oral daily administration from Days 1-12
• risperidone
13 day run-in phase until 4 mg daily dose level is reached. 4 mg daily oral dose until Day 17 of study, for a total of 30 days. Dose may be increased up to 6 mg at the investigator's discretion. After study treatment, risperidone dosage may be decreased, increased or omitted at the investigator's discretion during a wash-out phase while patients return to their chronic antipsychotic treatment. Patient response during wash-out will be monitored in-house for 48 hours after the last dose of RO5545965 or placebo is administered. This in-house observation may be extended as needed by the investigator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 10 weeks	No
Primary	Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs.		Up to 10 weeks	No
Secondary	Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965		17 days	No
Secondary	Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone		15 days	No