Bioavailability of LY03004 and Risperdal® Consta®

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091388
• Other study ID #: LY03004 MD
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2014
• Last updated: March 3, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• LY03004

• Risperdal® Consta®

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Community Clinical Research Inc	Austin	Texas
United States	Compass Research	Leesburg	Florida
United States	Woodland International	Little Rock	Arkansas
United States	Collaborative Neuroscience Network LLC	Long Beach	California
United States	CRI LifeTree	Marlton	New Jersey
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	CRI LifeTree	Philadelphia	Pennsylvania
United States	CBH Health LLC	Rockville	Maryland
United States	Comprehensive Clinical Development	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®		113 Days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		113 Days	Yes
Secondary	The change of the PANSS score for the Preliminary efficacy of LY03004		113 Days	No