NCT06719986

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

A Study to Characterize the Time Course of Reversal of Opioid (Fentanyl)-Induced Respiratory Depression Following Administration of Nalmefene Autoinjector 1.5 mg (0.94% MgCl2) Intramuscular and Narcan® 4 mg Intranasal in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).

Conditions

• Opioid Overdose

Interventions

Type	Name	Description
DRUG	Nalmefene HCl injection	Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
DRUG	Naloxone HCl intranasal	Naloxone 4 mg for intranasal (IN) administration

Timeline

• Start date: 2022-10-03
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2024-12-06
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study