Pharmacokinetic Study of Vivitrol in Healthy Participants

Opioid-use Disorder Clinical Trial

Official title: A Bioequivalence Study Comparing Vivitrol and O'Neil Long Acting Naltrexone Implant (OLANI) in Healthy Participants

Status Completed

Clinical Trial Summary

This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.

Clinical Trial Description

This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).

This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

• NCT number: NCT04716881
• Study type: Interventional
• Source: Go Medical Industries Pty Ltd
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2021
• Completion date: April 4, 2022