BIOPIN 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-07-01

Summary

This is a Phase 1b clinical study testing a new extended-release implant that delivers naltrexone, a medication used to treat opioid use disorder (OUD). The investigational product is called BIOPIN. It is a small implant that is inserted just under the skin of the thigh and slowly releases medication over many months. The goal of the study is to see what the blood levels of naltrexone are from two different doses of the BIOPIN implant over time and to compare it to blood levels of naltrexone from Vivitrol, an FDA-approved injectable form of extended-release naltrexone given once a month.

This study will enroll healthy adults between the ages of 18 and 55. Participants will be randomly assigned to receive either a low dose BIOPIN implant, a high dose BIOPIN implant, or monthly Vivitrol injections. All participants will be followed closely for 12 months to monitor medication levels in their blood and assess for any side effects or health changes. The study will help determine if the BIOPIN implant can deliver naltrexone levels that are equal to or higher than those seen with monthly Vivitrol injections, particularly during the times when patients are most vulnerable to relapse.

Participants receiving the BIOPIN implant will have the option of having the implant removed at the end of the study or choosing to continue being observed until the implant fully dissolves, which may take up to two years. Participants who choose extended follow-up will be enrolled in a separate observational study.

This study is sponsored by Drug Delivery Company, LLC, with support from the National Institute on Drug Abuse (NIDA). The clinical research is being overseen by Fast-Track Research, Inc. and reviewed by Advarra IRB. All participants will undergo screening exams to ensure they are healthy and eligible, and they will be closely monitored throughout the study.

The results of this study will help researchers determine the best dose of BIOPIN to move forward into later-stage clinical trials and may support further development of long-acting treatments for opioid use disorder that do not require monthly injections or surgical removal.

• Phase: PHASE1

Details

• Lead Sponsor: Drug Delivery Company, LLC DBA Akyso Pharmaceuticals
• Collaborators: Aliri Bioanalysis; Ardena; Cenexel JBR; Element Analytics; Fast-Track Drugs & Biologics, LLC; National Institute on Drug Abuse (NIDA)
• Treatments: Naltrexone