An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder

A Randomized, Open-Label Pharmacokinetic Study of LY03004 Compared to Risperdal® Consta® Following a Single Intramuscular Injection at 25 mg or 50 mg in Stable Patients With Schizophrenia and/or Schizoaffective Disorder

A review of the amount of drug in your blood over time.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange County, California, United States, 92868
      • Neuropsychiatric Research Center of Orange County
  • 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 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 acceptable representative

Exclusion Criteria:

1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV;
2. Patients who received oral risperidone or paliperidone or clozapine within 14 days prior to screening, or Risperdal® Consta® within 100 days or LY03004 within 80 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" on the questions 4 or 5 for current or past 30 days on the Baseline/Screening Version 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 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 less than 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 stablizers 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 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
ACTIVE_COMPARATOR: Risperdal® Consta®; 25 Mg or 50 mg	Drug: Risperdal® Consta®
EXPERIMENTAL: L03004; 25 mg or 50 mg	Drug: LY03004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax for the Pharmacokinetics (PK) of Risperdal® Consta®	57 days

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (ESTIMATE): July 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 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/CT-USA-104