NCT02687984

PK, Safety, and Tolerability Study of RBP-7000 of Different Molecular Weight Polymer in Subjects With Schizophrenia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	RBP-7000	A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-02-23
• Last updated: 2017-01-31

Locations

2 sites across 1 country: United States