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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02019329
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Other: Placebo; Drug: RO5545965; Drug: risperidone	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo + risperidone	Other: Placebo; Oral daily administration from Days 1-12; Drug: 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.
Experimental: RO5545965 + risperidone	Drug: RO5545965; Oral daily administration from Days 1-12; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events [Up to 10 weeks]

2. Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs. [Up to 10 weeks]

Secondary Outcome Measures

1. Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965 [17 days]

2. Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone [15 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Glendale	California	United States	91206

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02019329
• Other Study ID Numbers: BP29188
• First Posted: Dec 24, 2013
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Schizophrenia; Risperidone

Study Results

No Results Posted as of Nov 2, 2016