Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia

NCT02411526 | Completed Phase 1

• 1 other identifier: ZX003-1401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg

  Day 1 through day 120

Secondary Outcomes (2)

• Safety and tolerability of ZX003 as measured by assessing adverse events.

  Day 1 through day 120

• Safety and tolerability of ZX003 as measured by assessing laboratory values.

  Day 1 through day 120

Study Arms (4)

Cohort 1

EXPERIMENTAL

60 mg of ZX003 administered 4 times (every 4 weeks)

Drug: ZX003 (Risperidone-SABER®)

Cohort 2

EXPERIMENTAL

90 mg of ZX003 administered 4 times (every 4 weeks)

Drug: ZX003 (Risperidone-SABER®)

Cohort 3

EXPERIMENTAL

120 mg of ZX003 administered 4 times (every 4 weeks)

Drug: ZX003 (Risperidone-SABER®)

Cohort 4

ACTIVE COMPARATOR

Risperdal Consta administered 5 times (once every 2 weeks) NOTE: Oral risperidone 2 mg will be given with the first injection of Risperdal Consta and continued for 3 weeks (and then discontinued) to ensure adequate therapeutic plasma concentrations from Risperdal Consta.

Drug: Risperdal Consta; Drug: Oral Risperidone

Interventions

ZX003 (Risperidone-SABER®) DRUG

ZX003 administered as a SC injection

Also known as: Relday

Cohort 1; Cohort 2; Cohort 3

Risperdal Consta DRUG

Risperdal Consta administered as a IM injection

Also known as: risperidone

Cohort 4

Oral Risperidone DRUG

Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta

Also known as: risperdal

Cohort 4

Eligibility Criteria

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

You may qualify if:

• Male or female patients 18 - 60 years of age, inclusive.
• Diagnosis of schizophrenia, or schizoaffective disorder as per DSM-V criteria in the past 6 months or more, dependent on diagnosis.
• Currently on maintenance antipsychotic medication (ie, patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
• Body Mass Index (BMI) ≥20 and ≤40 kg/m2.
• Female patients who are non-childbearing potential (surgically sterile \[hysterectomy\]) or post-menopausal ≥2 years; or non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
• No clinically significant abnormal laboratory values.
• No clinically significant findings in the 12-lead ECG.
• No clinically significant findings from a vital signs measurement.
• Be informed of the nature of the study and give written consent prior to initiating any study procedure.

You may not qualify if:

• Unwilling to provide genotyping (phenotyping) sample for CYP2D6.
• Have known or suspected carcinoma.
• Have known presence or history of renal or hepatic insufficiency.
• Have known history, hypersensitivity or clinically significant idiosyncratic reaction to risperidone, paliperidone, and/or any other drug substance with similar activity.
• Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to Screening.
• Have a history of epilepsy or risk of having seizures.
• Are pregnant, lactating, or likely to become pregnant during the study.
• Have taken an antipsychotic depot product (including investigational products) within the 60 days prior to Screening.
• Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
• Have a positive alcohol breathalyzer test at Screening or Admission.
• Have a positive Screening test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• Have a positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines (unless prescribed), cannabinoids, etc.) at Screening or Admission.
• Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee).
• Use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Admission.
• Excessive smoking, defined as smoking more than 2 packs of cigarettes (or 5 cigars) per day for 1 year or greater.

Sponsors & Collaborators

• Zogenix, Inc.: lead

Study Sites (1)

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

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

• David Walling, PhD

  Collaborative Neuroscience Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 31, 2022

Record last verified: 2015-07

Locations

US (1)