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

NCT02019329 | Completed Phase 1

• 1 other identifier: BP29188
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Up to 10 weeks

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

  Up to 10 weeks

Secondary Outcomes (2)

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

  17 days

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

  15 days

Study Arms (2)

Placebo + risperidone

PLACEBO COMPARATOR

Other: Placebo; Drug: risperidone

RO5545965 + risperidone

EXPERIMENTAL

Drug: RO5545965; Drug: risperidone

Interventions

Placebo OTHER

Oral daily administration from Days 1-12

Placebo + risperidone

RO5545965 DRUG

Oral daily administration from Days 1-12

RO5545965 + risperidone

risperidone DRUG

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.

Placebo + risperidone; RO5545965 + risperidone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)