Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBP-7000 PLGH A | Experimental | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 21 kDa PLGH polymer. |
|
| RBP-7000 PLGH B | Experimental | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 29 kDa PLGH polymer. |
|
| RBP-7000 PLGH C | Active Comparator | A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 26 kDa PLGH polymer. This intermediate molecular weight treatment serves as the reference treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBP-7000 | Drug | A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial Burst Parameters: Cmax of risperidone | Maximum observed plasma concentration | 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. | approximately 0-24 hours; Day 1 to Day 2 |
| Secondary Peak Parameters: Cmax of risperidone | Maximum observed plasma concentration | 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. | approximately 24-672 hours; Day 2 to Day 29 |
| Overall Parameters: Cmax of risperidone | Maximum observed plasma concentration | 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. | Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Burst Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | approximately 0-24 hours; Day 1 to Day 2 |
| Initial Burst Parameters: AUC0-24h of 9-hydroxyrisperidone |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States | ||
| Collaborative Neuroscience Network |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 Peak Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | 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. | approximately 24-672 hours; Day 2 to Day 29 |
| Overall Parameters: Cmax of 9-hydroxyrisperidone | Maximum observed plasma concentration | 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. | Day 1 to Day 29 |
| Summary of Participants with Adverse Events | Day 1 to Day 29 |
| Torrance |
| California |
| 90502 |
| United States |