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.
This is a multicenter, randomized, open-label, single-dose, parallel-group study in subjects with clinically stable schizophrenia who are not currently taking risperidone. A total of approximately 48 subjects (16 per group) will be randomized to receive a single subcutaneous (SC) injection of RBP-7000 120 mg formulated with PLGH polymer of either 21 kilodaltons (kDa) (low MW group), 29 kDa of PLGH polymer (high MW group), or 26 kDa of PLGH polymer (intermediate MW group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer.
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States
Collaborative Neuroscience Network
Torrance, California, United States
Initial Burst Parameters: Cmax of risperidone
Maximum observed plasma concentration
Time frame: approximately 0-24 hours; Day 1 to Day 2
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.
Time frame: approximately 0-24 hours; Day 1 to Day 2
Secondary Peak Parameters: Cmax of risperidone
Maximum observed plasma concentration
Time frame: approximately 24-672 hours; Day 2 to Day 29
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.
Time frame: approximately 24-672 hours; Day 2 to Day 29
Overall Parameters: Cmax of risperidone
Maximum observed plasma concentration
Time frame: Day 1 to Day 29
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.
Time frame: Day 1 to Day 29
Initial Burst Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Time frame: approximately 0-24 hours; Day 1 to Day 2
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.
Time frame: approximately 0-24 hours; Day 1 to Day 2
Secondary Peak Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Time frame: approximately 24-672 hours; Day 2 to Day 29
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.
Time frame: approximately 24-672 hours; Day 2 to Day 29
Overall Parameters: Cmax of 9-hydroxyrisperidone
Maximum observed plasma concentration
Time frame: Day 1 to Day 29
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.
Time frame: Day 1 to Day 29
Summary of Participants with Adverse Events
Time frame: Day 1 to Day 29
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