NCT04716881

Pharmacokinetic Study of Vivitrol in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Go Medical Industries Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 57 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Naltrexone 380 MG	Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2021-01-20
• Last updated: 2024-02-23
• Results posted: 2023-06-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study