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Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults

NCT06216132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • Akyso Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · Cenexel JBR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-04-18
Completion
2025-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216132 on ClinicalTrials.gov