Bioavailability of LY03004 and Risperdal® Consta®

NCT ID: NCT02091388

Last Updated: 2015-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-01-31

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

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY03004 25 mg

5 intramuscular injections 25 mg over 113 days

Group Type: EXPERIMENTAL

LY03004

Intervention Type: DRUG

Risperdal® Consta® 25 mg

5 intramuscular injections 25 mg over 113 days

Group Type: ACTIVE_COMPARATOR

Risperdal® Consta®

Intervention Type: DRUG

Interventions

LY03004

Intervention Type: DRUG

Risperdal® Consta®

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Li

Role: STUDY_CHAIR

Luye Pharma Group Ltd.

Locations

Woodland International

Little Rock, Arkansas, United States

Collaborative Neuroscience Network LLC

Long Beach, California, United States

Neuropsychiatric Research Center of Orange County

Orange, California, United States

Comprehensive Clinical Development

Washington D.C., District of Columbia, 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

Marlton, New Jersey, United States

CRI LifeTree

Philadelphia, Pennsylvania, United States

Community Clinical Research Inc

Austin, Texas, United States

Countries

United States

References

Wang W, Wang X, Dong Y, Walling DP, Liu P, Liu W, Shi Y, Sun K. Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. Neurol Ther. 2024 Apr;13(2):355-372. doi: 10.1007/s40120-024-00578-w. Epub 2024 Jan 20.

Reference Type: DERIVED

PMID: 38244179 (View on PubMed)

Other Identifiers

LY03004 MD

Identifier Type: -

Identifier Source: org_study_id