CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
naltrexone implantdrug
Likely dose
naltrexone implant 1.8 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03810495
NCT03810495Phase 1Completed
CompareCT.gov

OLANI PK/Safety Study in Healthy Volunteers

Go Medical Industries Pty Ltd·interventional·Posted Jan 18, 2019·Updated Nov 12, 2024

In Brief

A Phase 1 clinical trial evaluating naltrexone implant for Opioid Use Disorder. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), New York State Psychiatric Institute, Columbia University, Clinilabs, Inc.

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 18, 2019
Enrollment StartApr 11, 2019
Primary CompletionMar 18, 2021
Study CompletionMar 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.5 years ago

Interventions

naltrexone implantdrug

1.8 g implant containing 60% naltrexone