Schizophrenia Clinical Trial
Official title:
A Multicenter, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of RBP-7000 Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) Compared to Intermediate Molecular Weight (Reference Treatment) Polymer in Subjects With Schizophrenia
Verified date | January 2017 |
Source | Indivior Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2
different molecular weights (MW) (low and high MW as test treatments) of poly
(DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to
intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in
subjects with stable schizophrenia.
Secondary Objective:
To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH
polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW
polymer in subjects with stable schizophrenia.
Status | Completed |
Enrollment | 44 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of schizophrenia as defined by DSM-5 criteria. - Clinically stable schizophrenia, as evidenced by the investigator evaluation, outpatient status for at least 30 days prior to screening, and confirmation of stability by a caregiver who has regular supportive contact with the subject. - Otherwise healthy on the basis of physical examination. - Body mass index (BMI) between 18 and 35 kg/m^2 and weight of at least 49.9 kg at screening. Exclusion Criteria: - Subjects taking any oral risperidone product (except the test doses of 0.25 mg of risperidone); or subjects taking any risperidone or 9-hydroxyrisperidone sustained-release or depot formulation within 120 days prior to study screening; or subjects who have received the 3-month depot formulation of 9-hydroxyrisperidone within 2 years of study screening. - Subjects taking a clinically relevant inducer or inhibitor of cytochrome P450 (CYP) 2D6, or CYP3A4, who have not undergone proper washout (minimum of 5 half-lives of the medication) of this prohibited medication prior to Day 1. - Medications, which in the opinion of the Investigator in conjunction with the medical monitor, may be expected to significantly interfere with metabolism or excretion of risperidone and/or 9-hydroxyrisperidone; may be associated with a significant drug interaction with risperidone; or may pose a significant risk to a subject's participation in the study. - Any natural products or herbal preparations including all vitamins and supplements throughout the study. - Subjects with a history of cancer unless disease-free for =5 years (with the exception of resected basal cell or squamous cell carcinoma of the skin). - Subjects with any other active medical condition/disorder/disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. - Subjects that had an exacerbation of schizophrenia in the last 30 days. - Subjects with evidence or history (in the past 6 months prior to screening) of a significant hepatic disorder that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug, including: - Acute or chronic hepatitis, including but not limited to hepatitis B or C. - Total bilirubin >1.5 x the upper limit of normal (ULN), or - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x ULN. - Subjects with a history of severe renal disease, or creatinine clearance <60 mL/min - Subjects with evidence or history of orthostatic hypotension within 6 months of screening. - Subjects with absolute neutrophil count <1.5x 10^9/L (African and African/American <1.2x 10^9/L). - Subjects with a history of drug-induced leucopenia. - Subjects who have acquired immune deficiency syndrome (AIDS) or to be human immunodeficiency virus (HIV)-positive. - Subjects with other medical conditions including, but not limited to, history of heart attack (myocardial infarction) or brain injury (traumatic injury with loss of consciousness and/or cerebrovascular accident), or clinically significant low blood pressure or arrhythmias as interpreted by the Principal Investigator or medically qualified sub-investigator. - Subjects with congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening, or a corrected QT interval (Fridericia - QTcF) >450 msec (male) or >470 msec (female) at screening (Visit 1). - Subjects with suicidal ideation with intent or plan - Subjects with uncontrolled depression, in the opinion of the Investigator. - Subjects with a diagnosis of insulin-dependent diabetes, or who have a hemoglobin A1c (HbA1c) =8.0% at screening, or have had changes in diabetic medication regimen in the 28 days prior to signing the informed consent document. - Subjects with prior allergic reactions, sensitivities or other known contraindications to any component of RBP-7000 (e.g., risperidone, PLGH or NMP). - Women of childbearing potential who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study. - Subjects with the presence of opioids, cocaine, amphetamines, methadone, barbiturates, benzodiazepines, methamphetamines, cannabinoids, or phencyclidine in the urine as assessed by a urine drug screen. - Subjects with epilepsy or other seizure disorders, Parkinson's disease or dementia. |
Country | Name | City | State |
---|---|---|---|
United States | Collaborative Neuroscience Network, LLC | Garden Grove | California |
United States | Collaborative Neuroscience Network | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Indivior Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial Burst Parameters: Cmax of risperidone | Maximum observed plasma concentration | approximately 0-24 hours; Day 1 to Day 2 | |
Primary | Initial Burst Parameters: AUC0-24h of risperidone | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose; calculated using the linear trapezoidal rule. | approximately 0-24 hours; Day 1 to Day 2 | |
Primary | Secondary Peak Parameters: Cmax of risperidone | Maximum observed plasma concentration | approximately 24-672 hours; Day 2 to Day 29 | |
Primary | Secondary Peak Parameters: AUCD2-D29 of risperidone | Area under the plasma concentration-time curve from 24 hours post-dose (Day 2) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule. | approximately 24-672 hours; Day 2 to Day 29 | |
Primary | Overall Parameters: Cmax of risperidone | Maximum observed plasma concentration | Day 1 to Day 29 | |
Primary | Overall Parameters: AUCD1-D29 of risperidone | Area under the plasma concentration-time curve from time 0 (Day 1) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule. | Day 1 to Day 29 | |
Secondary | Initial Burst Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | approximately 0-24 hours; Day 1 to Day 2 | |
Secondary | Initial Burst Parameters: AUC0-24h of 9-hydroxyrisperidone | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose; calculated using the linear trapezoidal rule. | approximately 0-24 hours; Day 1 to Day 2 | |
Secondary | Secondary Peak Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | approximately 24-672 hours; Day 2 to Day 29 | |
Secondary | Secondary Peak Parameters: AUCD2-D29 of 9-hydroxyrisperidone | Area under the plasma concentration-time curve from 24 hours post-dose (Day 2) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule. | approximately 24-672 hours; Day 2 to Day 29 | |
Secondary | Overall Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | Day 1 to Day 29 | |
Secondary | Overall Parameters: AUCD1-D29 of 9-hydroxyrisperidone | Area under the plasma concentration-time curve from time 0 (Day 1) to 672 hours post-dose (Day 29); calculated using the linear trapezoidal rule. | Day 1 to Day 29 | |
Secondary | Summary of Participants with Adverse Events | Day 1 to Day 29 |
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