NCT02710526

Phase II Pharmacokinetics Study of CAM2038

A Phase II, Open-label, Partially Randomized, 3 Treatment Groups, Multi-Site Study Assessing Pharmacokinetics After Administration of the Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) at Different Injection Sites in Opioid-Dependent Subjects With Chronic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Braeburn Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.

Detailed description

This is a phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038 weekly and monthly at different injection sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects with a history of chronic non cancer pain. The study will involve three phases: Screening, Treatment, and Follow up.

Conditions

• Opioid Use Disorder
• Chronic Pain

Interventions

Type	Name	Description
DRUG	CAM2038	Long-Acting Subcutaneous Injectable Depot of Buprenorphine

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-05-17
• Completion: 2017-07-03
• First posted: 2016-03-16
• Last updated: 2020-04-30
• Results posted: 2020-04-30

Locations

3 sites across 1 country: United States