Bioavailability of LY03004 and Risperdal® Consta®

NCT02091388 | Completed Phase 1

• 1 other identifier: LY03004 MD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 10

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

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Cmax, Tmax, for Relative bioavailability of LY03004 compared to Risperdal® Consta®

  113 Days

Secondary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  113 Days

• The change of the PANSS score for the Preliminary efficacy of LY03004

  113 Days

Study Arms (2)

LY03004 25 mg

EXPERIMENTAL

5 intramuscular injections 25 mg over 113 days

Drug: LY03004

Risperdal® Consta® 25 mg

ACTIVE COMPARATOR

5 intramuscular injections 25 mg over 113 days

Drug: Risperdal® Consta®

Interventions

LY03004 DRUG

LY03004 25 mg

Risperdal® Consta® DRUG

Risperdal® Consta® 25 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 to 65 years old
• Patients must have a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder based on the Mini-International Neuropsychiatric Interview (MINI)
• 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
• Patients with a Body Mass Index in range of 18.0 to 35.0
• Patients with an Informed Consent Form signed by the patient or legally authorized representative

You may not qualify if:

• Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV-TR
• 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
• Patients with neuroleptic malignant syndrome or physical fatigue associated with dehydration or malnutrition
• 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)
• Patients with a history of sensitivity to akathisia and other EPS, especially with previous use of risperidone or paliperidone
• Patients with uncontrolled diabetes mellitus as indicated by a HbA1c level greater than or equal to 7%
• Patients with a history of or currently having epilepsy or convulsion disorders
• Patients who have had electroconvulsive therapy within the past 2 months prior to screening
• Patients who used medication known to be an inducer or inhibitor for CYP 2D6 within 2 weeks prior to screening
• Patients with a history of allergic reaction to risperidone or to the excipients of LY03004
• 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
• Patients with a history of clinically relevant cardiac arrhythmia's, cardiovascular disease, thyrotoxicosis, parkinsonism, or hemorrhagic diathesis
• Patients who are currently taking medications with primarily CNS activities such as antidepressants, mood stabilizers or anticonvulsants
• Patients who have participated in a clinical trial of another investigational drug within 30 days prior to screening
• Female patients who are pregnant or are breastfeeding or are of childbearing potential without adequate use of contraception

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (10)

Woodland International

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Network LLC

Long Beach, California, 90806, United States

Location

Neuropsychiatric Research Center of Orange County

Orange, California, 92868, United States

Location

Comprehensive Clinical Development

Washington D.C., District of Columbia, 20016, United States

Location

Compass Research

Leesburg, Florida, 34748, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

CBH Health LLC

Rockville, Maryland, 20850, United States

Location

CRI LifeTree

Marlton, New Jersey, 08053, United States

Location

CRI LifeTree

Philadelphia, Pennsylvania, 19139, United States

Location

Community Clinical Research Inc

Austin, Texas, 78754, United States

Location

Related Publications (1)

• 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.

  PMID: 38244179 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Simon Li

  Luye Pharma Group Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 19, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

US (10)