NCT02765867

Single-dose, Study of RBP-6000 in Opioid Dependent Individuals

A Single-Dose, Open-Label Study of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Individuals

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.

Detailed description

This is an open-label, single-center, first-in-human study, designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of a single subcutaneous (SC) injection of RBP-6000 in opioid dependent subjects. Enrollment will begin with 6 subjects, and additional subjects will not be enrolled until safety through Day 4 has been reviewed and analyzed. Subjects will remain in a residential unit through Day 30 post-injection and will continue with visits to the clinical unit until Day 85 or plasma buprenorphine levels are below 100 pg/mL, whichever comes later. The expected maximum duration of participation for each subject (including screening) is 120 days. Safety will be assessed by adverse events, electrocardiograms, clinical laboratory assessments, local injection site tolerability and vital signs. PK will be assessed by measuring concentrations of buprenorphine and norbuprenorphine in plasma. The need for rescue medication will be assessed using clinical judgment along with information provided by the COWS scores.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	RBP-6000	A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2016-05-09
• Last updated: 2016-05-09

Locations

1 site across 1 country: United States