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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02091388
Other study ID # LY03004 MD
Secondary ID
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


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
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