- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572685
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
A Randomized, Open-Label, Parallel, Single-Dose Study to Evaluate the Pharmacokinetic Characteristics of LY03010 Process 1 and Process 2 Drug Product Versus INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, open-label, parallel-group, single-dose study. Patients will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. About 36 patients will be randomized in a 1:1:1 ratio to 1 of 3 treatment groups. Patients will be admitted to the clinical facility the day before dosing (Day 0) and will be receiving an IM injection of study drug and completing the assigned study activity including PK sample collection on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures. End of study evaluation will be completed on Day 120.
Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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New Jersey
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Berlin, New Jersey, United States, 08009
- Hassman Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female ≥18 to ≤65 years of age who meets diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening
- Have been on a stable dose of oral antipsychotic medication(s) other than risperidone, paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to screening
- Clinically stable based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score ≤70 as well as a PANSS HATE (hostility, anxiety, tension and excitement) subtotal score <16 at screening
- Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive
- Body mass index (BMI) ≥17.0 and ≤37kg/m2; body weight ≥50 kg
- Creatinine level within the normal range
- All female patients (childbearing potential and non-childbearing potential) must have a negative pregnancy test result at both screening and baseline.
- Sexually active fertile male patients must be willing to use acceptable contraception methods (such as double barrier methods of a combination of male condom with either cap, diaphragm or sponge with spermicide) from study drug dosing, throughout the study, and for another 80 days after the EOT visit (or at least 200 days after the dose, whichever is longer) if their partners are women of childbearing potential.
Exclusion Criteria:
- Primary and active DSM-V Axis I diagnosis other than schizophrenia
- Patients who meet DSM-V criteria for substance abuse (moderate or severe) with the exception of caffeine or nicotine in the past 6 months prior to screening, or test positive for barbiturate or alcohol at screening or baseline
Patients who received any of following treatment:
- Use of oral risperidone or paliperidone within 2 weeks before screening.
- Use of clozapine, thioridazine or ziprasidone within 4 weeks before screening.
- Use of 2-week depot formulation of risperidone within 3 months, 1-month depot formulation of risperidone or 9-hydroxy risperidone (INVEGA SUSTENNA) within 1 year,
- Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test should be completed during the screening period
- QTcF interval greater than 450 msec for males and 470 msec for females or a prior history or presence of circumstances
- Medical history (within 2 years) of clinically significant, gastrointestinal, cardiovascular, cerebrovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, neurologic, immunologic disorders, or drug hypersensitivity which, in the judgement of the Investigator, would interfere with the patient's ability to participate in the study
- History of dementia-related psychosis or Parkinson's Disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LY03010 Process 1
Drug Product of Process 1 ( P1): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study. LY03010 P1 using a non-sterile Active Pharmaceutical Ingredients (API) with an absolute ethanol recrystallization was manufactured by an optimized production process |
A long acting extended release injectable suspension intended for monthly intramuscular administration
Other Names:
|
EXPERIMENTAL: LY03010 Process 2
Drug Product of Process 2 (P2): 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study. LY03010 P2 using a sterile Active Pharmaceutical Ingredients (API) with an isopropanol recrystallization was manufactured by the same optimized production process as that used in P1. |
A long acting extended release injectable suspension intended for monthly intramuscular administration
Other Names:
|
EXPERIMENTAL: INVEGA SUSTENNA
INVEGA SUSTENNA 156 mg/vial; Single Injection on Day 1 during the entire 120 Day's study
|
A long acting extended release injectable suspension intended for monthly intramuscular administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize the Maximum Plasma Concentration [Cmax]of LY03010 P1, P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients
Time Frame: 120-Day
|
The Cmax of LY03010 P1, P2 and INVEGA SUSTENNA will be measured
|
120-Day
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To characterize Area under the plasma concentration versus time curve (AUC) of LY03010 P1 and P2 and INVEGA SUSTENNA following a single IM injection of 156 mg dosage level in schizophrenia patients.
Time Frame: 120-Day
|
The AUCs of LY03010 P1, P2 and INVEGA SUSTENNA will be evaluated
|
120-Day
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To compare the Cmax of LY03010 P1 and P2 with the Cmax of INVEGA SUSTENNA
Time Frame: 120-Day
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The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
|
120-Day
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To compare the AUCs of LY03010 P1 and P2 with the AUCs of INVEGA SUSTENNA
Time Frame: 120-Day
|
The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed
|
120-Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and tolerability of tested drugs. Safety assessments include Incidence of adverse events.
Time Frame: 120 day
|
AE will be monitored throughout of the study course
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120 day
|
To evaluate the safety of the tested drugs-- Incident of abnormal vital sign
Time Frame: 120 Day
|
Vital Sign will be measured on Day1 ,2, 4, 6, 8,10,12,15, 17,19, 22 ,29, 64, 92 and Day 120
|
120 Day
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To evaluate the safety of the tested drugs-- Incident of abnormal ECG Findings
Time Frame: 120 Day
|
12-Lead ECG will be measured on Day 0, 29, 64, 92 and Day 120
|
120 Day
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To evaluate any abnormal movement symptoms measured by Abnormal Involuntary Movement Scale (AIMS). AIMS measures movement of each part of body muscle with score range of 0-4, 0 means None and 4 means Severe.
Time Frame: 120-Day
|
AIMS will be measured on Day 0, 15, 29, 64, 92 and Day 120
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120-Day
|
To evaluate any abnormal movement symptoms measured by Barnes Akathisia Rating Scale (BARS). BARS is a rating scale for drug-induced akathisia with a range of 0-14; 0 means Normal and 14 means Severe.
Time Frame: 120-Day
|
BARS will be measured on Day 0, 15, 29, 64, 92 and Day 120
|
120-Day
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To evaluate any suicidal attempts measured by Columbia Suicide Severity Rating Scale ( C-SRRS). C-SRRS measures the suicidal intensity of ideation and attempt with score of 1-5; 1 means the least severe and 5 means the most severe.
Time Frame: 120-Day
|
C-SSRS will be measured on Day 0, 29, 64, 92 and Day 120
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120-Day
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Luye Pharma, Luye Pharma Group
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- LY03010/CT-USA-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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