Schizophrenia | Bioavailability of LY03004 and Risperdal® Consta®
Schizophrenia research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LY03004 25 mg5 intramuscular injections 25 mg over 113 days
Risperdal® Consta® 25 mg5 intramuscular injections 25 mg over 113 days
Start Date: September 2014
Completed Date: January 2015
Phase: Phase 1
Primary Outcome: Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®
Secondary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study sponsors, principal investigator, and references
Principal Investigator: Simon Li
Lead Sponsor: Luye Pharma Group Ltd.