Schizophrenia Patients Clinical Trial
Official title:
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
Verified date | November 2020 |
Source | Luye Pharma Group Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2 with that of INVEGA SUSTENNA® following a single IM injection of 156 mg dosage level.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 20, 2020 |
Est. primary completion date | June 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hassman Research Institute | Berlin | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Luye Pharma Group Ltd. | Alliance for Clinical Trials in Oncology, Evolution Research Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The Cmax of LY03010 P1, P2 and INVEGA SUSTENNA will be measured | 120-Day | |
Primary | 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. | The AUCs of LY03010 P1, P2 and INVEGA SUSTENNA will be evaluated | 120-Day | |
Primary | To compare the Cmax of LY03010 P1 and P2 with the Cmax of INVEGA SUSTENNA | The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed | 120-Day | |
Primary | To compare the AUCs of LY03010 P1 and P2 with the AUCs of INVEGA SUSTENNA | The relative bioavailability of LY03010 P1 and P2 to Invega Sustenna will be assessed | 120-Day | |
Secondary | To evaluate the safety and tolerability of tested drugs. Safety assessments include Incidence of adverse events. | AE will be monitored throughout of the study course | 120 day | |
Secondary | To evaluate the safety of the tested drugs-- Incident of abnormal vital sign | 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 | |
Secondary | To evaluate the safety of the tested drugs-- Incident of abnormal ECG Findings | 12-Lead ECG will be measured on Day 0, 29, 64, 92 and Day 120 | 120 Day | |
Secondary | 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. | AIMS will be measured on Day 0, 15, 29, 64, 92 and Day 120 | 120-Day | |
Secondary | 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. | BARS will be measured on Day 0, 15, 29, 64, 92 and Day 120 | 120-Day | |
Secondary | 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. | C-SSRS will be measured on Day 0, 29, 64, 92 and Day 120 | 120-Day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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