NCT02768649

Single Ascending Dose Study of RBP-7000

A Phase I, Open Label, Single Center, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of RBP-7000 at Low, Medium, and High Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and tolerability of injections of RBP-7000 in subjects with stable schizophrenia

Detailed description

This was an open-label, single-center, Phase 1, single ascending dose study, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single SC injection of low, medium and high doses of RBP-7000 in subjects with clinically stable schizophrenia who were not taking risperidone. The design was a sequential cohort with treatment initiated in 3 cohorts after safety and tolerability at a lower dose were confirmed. Eligible subjects received a single oral test dose of 0.25mg risperidone under medical supervision. Subjects who continued to be eligible were admitted to a residential unit for approximately 14 days, and received a single dose of RBP-7000. Subjects were discharged on Day 15 and returned to the clinical site weekly for approximately 10 weeks.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	RBP-7000	Sequential dosing of each cohort
DRUG	risperidone	All eligible subjects received a test dose of risperidone to ensure tolerability prior to dosing with RBP-7000.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2016-05-11
• Last updated: 2016-05-11

Locations

1 site across 1 country: United States