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

Phase 1

Completed

• Conditions: Opioid Overdose
• Interventions: Drug: Nalmefene HCl injection; Drug: Naloxone HCl intranasal

• Registration Number: NCT06719986
• Lead Sponsor: Purdue Pharma LP

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nalmefene Hydrochloride (HCl) injection	Nalmefene HCl injection	Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
Narcan intranasal	Naloxone HCl intranasal	Naloxone 4 mg for intranasal (IN) administration

Primary Outcome Measures

Name	Time	Method
Change in Minute Ventilation 5 minutes from opioid induced nadir	5 minutes after opioid antagonist administration	to assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.

Secondary Outcome Measures

Name	Time	Method
Change in Minute Ventilation at 2.5, 10, 15, 20, and 90 minutes from opioid induced nadir	2.5, 10, 15, 20, and 90 minutes after opioid antagonist administration	To assess the time course of changes in minute ventilation of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.
Maximum Plasma Concentration (Cmax)	up to 24 hours post-dose	Maximum plasma concentration of nalmefene and naloxone.
Area Under the Curve (AUC0-2.5)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to 2.5 minutes
Area Under the Curve (AUC0-5)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to 5 minutes
Area Under the Curve (AUC0-10)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to 10 minutes
Area Under the Curve (AUC0-15)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to 15 minutes
Area Under the Curve (AUC0-20)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to 20 minutes
Area Under the Curve (AUCt)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to the time of last measurable concentration.
Area Under the Curve (AUCinf)	up to 24 hours post-dose	Area under the plasma concentration-time curve from time zero to infinity.
Time to Maximum Plasma Concentration (Tmax)	up to 24 hours post-dose	Time to maximum plasma concentration of nalmefene and naloxone.
Time to first measurable plasma concentration (Tlag)	up to 24 hours post-dose	Time to first measurable plasma concentration of nalmefene and naloxone.
Half-life (T1/2)	up to 24 hours post-dose	Half life of nalmefene and naloxone.

Trial Locations

Locations (1)

Ohio Clinical Trials; 🇺🇸 Columbus, Ohio, United States