A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia

NCT01592110 | Completed Phase 1 DMC

• 1 other identifier: ZX003-1101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER

  Within 35 days post-dose

• Maximum plasma concentration, time of maximum plasma concentration and area under the concentration time curve for risperidone, 9-OH risperidone and active moiety (risperidone + 9-OH risperidone)

  Within 35 days post-dose

Study Arms (4)

Cohort 1

EXPERIMENTAL

25 mg of risperidone-SABER administered as a SC injection of 0.25 mL (100 mg/mL concentration) in the abdominal region

Drug: risperidone-SABER

Cohort 2

EXPERIMENTAL

50 mg of ZX003 (risperidone-SABER-DosePro) administered as 0.5 mL (100 mg/mL concentration) via the DosePro Needle-free Delivery System in the abdominal region

Other: ZX003:risperidone-SABER and the DosePro System

Cohort 3

EXPERIMENTAL

50 mg of risperidone-SABER administered as a SC injection of 0.5 mL (100 mg/mL concentration) in the abdominal region

Drug: risperidone-SABER

Cohort 4

EXPERIMENTAL

100 mg of risperidone-SABER administered as a SC injection of 1.0 mL (100 mg/mL concentration) in the abdominal region

Drug: Risperidone-SABER

Interventions

Risperidone-SABER DRUG

25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL

Cohort 1

ZX003:risperidone-SABER and the DosePro System OTHER

50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years of age or older.
• Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as per DSM-IV criteria in the past 6 months or more, dependent on diagnosis.
• Currently on maintenance antipsychotic medication (i.e., 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) (kg/m2) ≥ 20 and ≤ 40.
• Female patients with:
• 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 electrocardiogram (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:

• Have known or suspected carcinoma.
• Have known presence or history of renal or hepatic insufficiency.
• Have known history, hypersensitivity or idiosyncratic reaction (including dystonias) to risperidone, paliperidone, and/or any other drug substance with similar activity.
• Have a history of alcohol or drug-dependence as per DSM-IV 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, cannabinoids, etc.) at Screening or Admission.
• Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee).
• Are unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Admission until End-of-Study.
• Excessive smoking as judged by the Investigator
• Donation of blood (\> 500 mL) or blood products within 2 months (56 days) prior to Admission.

Sponsors & Collaborators

• Zogenix, Inc.: lead

Study Sites (1)

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Lev G Gertsik, MD

  Parexel

  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: May 1, 2012
• First Posted: May 7, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 10, 2022

Record last verified: 2013-07

Locations

US (1)