The purpose of this study is to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone.
Twelve subjects with stable schizophrenia will be enrolled. The expected duration of participation is 88 days which includes at least a 2 days screening and an 85 day treatment period (15 -day inpatient stay in the clinical unit and an additional 70-day outpatient period, including the Day 85 end of study follow up or early termination visit. Visits will occur approximately weekly during the outpatient period. Neurological and clinical symptom assessments (Positive and Negative Syndrome Scale \[PANSS\], Clinical Global Impressions-Schizophrenic Specific \[CGI-SCH\], Simpson-Angus Scale \[SAS\], Barnes Akathisia Scale \[BAS\], and Columbia-Suicide Severity Rating Scale \[C-SSRS\]) will be conducted at screening, on the day of admission to the clinical unit (Day -1), and at each post-dose visit throughout the study including the follow-up visit. Scale results will be reviewed by the Principal Investigator. The Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia will be performed at screening and at each post-dose visit throughout the study including the end of study follow-up visit. CYP-2D6 genotyping will be conducted at screening. Tolerability will be measured using SAS, which will be conducted as described above. Blood samples to assess the PK parameters will be taken from pre-dose until approximately 84 days post-dose. End of study procedures will be conducted on follow-up Day 85 (84 days post-dose) or early termination (ET) to assess any adverse events (AEs) that were ongoing at the last visit, any new AEs that have developed, and for measurement of safety parameters.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single dose
CRI Worldwide
Willingboro, New Jersey, United States
Incidence of treatment emergent adverse and serious adverse events after a single injection of RBP-7000
Adverse events, serious adverse events, discontinuations due to AEs, local injection site tolerability, vital signs, physical examinations, laboratory results, use of concomitant medications, clinical symptom assessments, 12-lead ECGs
Time frame: Day 1-Day 85
Maximum plasma concentration (Cmax) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Time frame: Pre-Dose to 84 days post-dose
Time of occurrence of Cmax (Tmax) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Time frame: Pre-Dose to 84 days post-dose
Area under the plasma concentration versus time curve (AUC) after a single injection of RBP-7000
PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.
Time frame: Pre-Dose to 84 days post-dose
AUC last after a single injection of RBP-7000
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Time frame: Day 85
C last
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Time frame: Day 85
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T last
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Time frame: Day 85
Apparent elimination rate constant (AUC0-∞, λz)
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Time frame: Pre-dose to 84 days post-dose
Half life (T1/2)
Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).
Time frame: Pre-dose to 84 days post-dose
Cmax versus RISPERDAL® CONSTA® historical data
The distribution of RBP-7000 compared to those obtained in a previous single-dose study of RISPERDAL® CONSTA®.
Time frame: Pre-Dose to 84 days post-dose