Back to results

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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

RO5545965

risperidone

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo + risperidone

RO5545965 + risperidone

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02019329

First Posted

December 18, 2013

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02019329

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo + risperidone

Arm Type

Placebo Comparator

Arm Title

RO5545965 + risperidone

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Oral daily administration from Days 1-12

Intervention Type

Drug

Intervention Name(s)

RO5545965

Intervention Description

Oral daily administration from Days 1-12

Intervention Type

Drug

Intervention Name(s)

risperidone

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

Up to 10 weeks

Title

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 Outcome Measure Information:

Title

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

Time Frame

17 days

Title

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

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs