At a glance
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A Phase 1, Placebo-controlled, Single-Ascending-Dose, Study of BIOPIN 6 in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating BIOPIN-6 Active Implant with Naltrexone and BIOPIN-6 Placebo Implant for Opioid Use Disorder. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
An extended release formulation of naltrexone implanted in the subcutaneous space.
The placebo will be an implant consisting of the poly-d-l Lactic Acid and polycaprolactone contained in BIOPIN 6 without naltrexone.