Overview

OLANI PK/Safety Study in Healthy Volunteers

Status:
Completed
Trial end date:
2021-03-22
Target enrollment:
Participant gender:
Summary
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
Phase:
Phase 1
Details
Lead Sponsor:
Go Medical Industries Pty Ltd
Collaborators:
Clinilabs, Inc.
Columbia University
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Treatments:
Naltrexone