Bioavailability of LY03004 and Risperdal® Consta®

Phase 1

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Drug: Risperdal® Consta®; Drug: LY03004

• Registration Number: NCT02091388
• Lead Sponsor: Luye Pharma Group Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Study Start: 2014-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperdal® Consta® 25 mg	Risperdal® Consta®	5 intramuscular injections 25 mg over 113 days
LY03004 25 mg	LY03004	5 intramuscular injections 25 mg over 113 days

Primary Outcome Measures

Name	Time	Method
Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®	113 Days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Neuropsychiatric Research Center of Orange County; 🇺🇸 Orange, California, United States

Collaborative Neuroscience Network LLC; 🇺🇸 Long Beach, California, United States

Compass Research; 🇺🇸 Leesburg, Florida, United States

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States

CBH Health LLC; 🇺🇸 Rockville, Maryland, United States

CRI LifeTree; 🇺🇸 Philadelphia, Pennsylvania, United States

Community Clinical Research Inc; 🇺🇸 Austin, Texas, United States

Woodland International; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive Clinical Development; 🇺🇸 Washington, District of Columbia, United States