Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)

Opiod Use Disorder Clinical Trial

Official title: Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching From Oral Naltrexone HCL to DLP-160 (Naltrexone Implant) to Intramuscular Vivitrol®

Status Completed

Clinical Trial Summary

This is an Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Naltrexone HCL to DLP-160 (Naltrexone implant) to Intramuscular Vivitrol®

Clinical Trial Description

This study is first-in-man clinical study of DLP-160, a Naltrexone implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-160 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral and injectable forms of Naltrexone.

Initially, a group of 2 healthy volunteers will receive the Naltrexone HCL followed by DLP-160 implant as a sentinel group. The safety and tolerability of the DLP-160 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being implanted with DLP-160 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the Investigator, will the remainder of healthy volunteers commence treatment in the study.

Healthy volunteers will be enrolled and implanted with DLP-160 involving treatment of each study participant consisting of 3 sequential treatment periods with a washout period between treatments.

1. Naltrexone HCL treatment (oral; 50 mg/day) (Day -6 to Day -2);

2. Washout (Day -1);

3. DLP-160 implant treatment (up to 123 days);

4. DLP-160 removal and washout (1 day);

5. Vivitrol® treatment (single intramuscular injection with a 30 day follow up);

6. Follow up to completion of study participation (7 days). ;

Related Conditions & MeSH terms

• Opiod Use Disorder

• NCT number: NCT05304364
• Study type: Interventional
• Source: Delpor, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2022
• Completion date: November 19, 2022