Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder

Schizophrenia Clinical Trial

— LY03004SAD  

Official title:

An Open-Label, Single Ascending Dose Pharmacokinetic and Safety Study of LY03004 Following Escalating Single Intramuscular Injection in Stable Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055287
• Other study ID #: LY03004
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2014
• Last updated: November 7, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• 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

The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the safety and tolerability and preliminary efficacy of LY03004 following intramuscular injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• 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 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 to 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 acceptable representative

Exclusion Criteria:

1. Patients with a mental disorders other than schizophrenia or schizoaffective disorder, according to the DSM-IV;

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" on 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 less than 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 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: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• LY03004

Locations

Country	Name	City	State
United States	Community Clinical Research Inc	Austin	Texas
United States	Neuropsychiatric Research Center of Orange County	Orange	California

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 for the Pharmacokinetics (PK) of LY03004		43 Days	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		43 Days	Yes
Secondary	The change of the PANSS score for the Preliminary efficacy of LY03004		43 Days	No