NCT06216132

Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults

A Phase 1, Placebo-controlled, Single-Ascending-Dose, Study of BIOPIN 6 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Akyso Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years. To do this, the implant containing the drug will be inserted under the skin, left in place for 3 months and then removed.

Detailed description

Naltrexone (NTX) is a medication that helps people with opioid and alcohol dependence. It works by blocking the effects of opioids like heroin in the body. In the United States, participants can get NTX in two forms: a pill participants take once a day (Revia) and a shot participants get once a month (Vivitrol). Even though NTX is good at stopping the effects of opioids, some people find it hard to take it regularly. That's why scientists are looking into making a new version of NTX that participants only need to take once a month. This could make it easier for people with opioid use problems to stick with their treatment plan. The device being tried out in this research is called BIOPIN-6. It's made to stay in the body for more than a month. The study will go on for three months and aims to check if the BIOPIN-6 is safe and how much medicine it releases into the blood. Once the three months are up, the device will be taken out.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BIOPIN-6 Active Implant with Naltrexone	An extended release formulation of naltrexone implanted in the subcutaneous space.
DEVICE	BIOPIN-6 Placebo Implant	The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone.

Timeline

• Start date: 2024-06-24
• Primary completion: 2025-04-18
• Completion: 2025-04-25
• First posted: 2024-01-22
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study