Bioavailability of LY03004 and Risperdal® Consta®

A Randomized, Open-Label, Parallel-Group Study to Assess the Relative Bioavailability of LY03004 and Risperdal® Consta® at 25 mg Following Multiple Intramuscular Injections in Stable Patients With Schizophrenia or Schizoaffective Disorder

This study is to assess the bioavailability of LY03004 compared to Risperdal Consta as well as the evaluate the safety and tolerability and preliminary efficacy of LY03004 with repeat injections

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Risperdal® Consta®; Drug: LY03004

Detailed Description

• To assess the relative bioavailability of LY03004 compared to Risperdal® Consta® at 25 mg following multiple intramuscular injections at steady-state;
• To evaluate the safety and tolerability of LY03004 following repeated intramuscular injections
• To evaluate the preliminary efficacy of LY03004 following repeated intramuscular injections

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International
  • California
    • Long Beach, California, United States, 90806
      • Collaborative NeuroScience Network LLC
    • Orange, California, United States, 92868
      • Neuropsychiatric Research Center of Orange County
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Comprehensive Clinical Development
  • Florida
    • Leesburg, Florida, United States, 34748
      • Compass Research
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta Center for Medical Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • CBH Health LLC
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • CRI Lifetree
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Lifetree
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged 18 to 65 years old
2. Patients must have a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI)
3. Patients must be clinically stable on antipsychotic medications other than risperidone or paliperidone or clozapine for at least 4 weeks prior to screening, based on clinical assessments AND a Positive and Negative Syndrome Scale (PANSS) total score less than or equal 70 at Screening Visit
4. Patients with a Body Mass Index in range of 18.0 to 35.0
5. Patients with an Informed Consent Form signed by the patient or legally authorized representative

Exclusion Criteria:

1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR
2. Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days prior to screening or paliperidone palmitate within 10 months prior to screening
3. Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition
4. Patients who pose a significant risk of a suicide attempt based on history, investigator's judgment or have answered "yes" to the questions 4 or 5 for current or past 30 days on the screening form of the Columbia Suicide Severity Rating Scale (C-SSRS)
5. Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone
6. Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal to 7%
7. Patients with a history of or currently having epilepsy or convulsion disorders
8. Patients who have had electroconvulsive therapy within the past 2 months prior to screening
9. Patients who used medication known to be an inducer or inhibitor for CYP 2D6 within 2 weeks prior to screening
10. Patients with a history of allergic reaction to risperidone or to the excipients of LY03004
11. Patients who have met DSM-IV-TR criteria for substance abuse or dependence with the exception of caffeine or nicotine in the past 6 months prior to screening
12. Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis
13. Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stabilizers or anticonvulsants
14. Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening
15. Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate use of contraception
16. Patients who have any clinically relevant hepatic, renal and cardiac dysfunction, or other medical condition or laboratory abnormality, which in the judgment of the investigator would interfere with the subject's ability to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY03004 25 mg; 5 intramuscular injections 25 mg over 113 days	Drug: LY03004
ACTIVE_COMPARATOR: Risperdal® Consta® 25 mg; 5 intramuscular injections 25 mg over 113 days	Drug: Risperdal® Consta®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®	113 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	113 Days
The change of the PANSS score for the Preliminary efficacy of LY03004	113 Days

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (ESTIMATE): March 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 4, 2015
• Last Update Submitted That Met QC Criteria: March 3, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: LY03004 MD