NCT05304364

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Delpor, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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®

Detailed 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).

Conditions

• Opiod Use Disorder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination Product: Naltrexone	Naltrexone Implant

Timeline

• Start date: 2022-03-22
• Primary completion: 2022-10-21
• Completion: 2022-11-19
• First posted: 2022-03-31
• Last updated: 2025-02-13

Locations

1 site across 1 country: Australia