Clinical trial NCT02091388: Bioavailability of LY03004 and Risperdal® Consta®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
timeFrame: 113 Days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 113 Days
measure: The change of the PANSS score for the Preliminary efficacy of LY03004
timeFrame: 113 Days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International
state: Arkansas
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network LLC
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Washington
country: United States
facility: Comprehensive Clinical Development
state: District of Columbia
city: Leesburg
country: United States
facility: Compass Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Rockville
country: United States
facility: CBH Health LLC
state: Maryland
city: Marlton
country: United States
facility: CRI LifeTree
state: New Jersey
city: Philadelphia
country: United States
facility: CRI LifeTree
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research Inc
state: Texas
Study officials:
affiliation: Luye Pharma Group Ltd.
name: Simon Li
role: STUDY_CHAIR
References: