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

NCT06719986 | Completed Phase 1 Results FDA Drug

• 1 other identifier: NAL1004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir

  To assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.

  5 minutes after opioid antagonist administration

Secondary Outcomes (12)

• Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir

  Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration

• Maximum Plasma Concentration (Cmax)

  up to 24 hours post-dose

• Area Under the Curve (AUC0-2.5)

  2.5 minutes post-dose

• Area Under the Curve (AUC0-5)

  5 minutes post-dose

• Area Under the Curve (AUC0-10)

  10 minutes post-dose

Study Arms (2)

Nalmefene Hydrochloride (HCl) injection

EXPERIMENTAL

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Drug: Nalmefene HCl injection

Narcan intranasal

ACTIVE COMPARATOR

Naloxone 4 mg for intranasal (IN) administration

Drug: Naloxone HCl intranasal

Interventions

Nalmefene HCl injection DRUG

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Nalmefene Hydrochloride (HCl) injection

Naloxone HCl intranasal DRUG

Naloxone 4 mg for intranasal (IN) administration

Also known as: Narcan

Narcan intranasal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
• Body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (BMI) within the range \[18-30\] kg/m2 (inclusive).
• Willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable.

You may not qualify if:

• Females who are pregnant or lactating.
• Any significant illness during the 30 days preceding the initial dose in this study.
• History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
• Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
• Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit.
• Difficulty with venous access or unsuitable for or unwilling to undergo catheter insertion.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (1)

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Opiate Overdose

Interventions

nalmefene; Naloxone

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Leader
• Organization: Purdue Pharma

Purduemedinfo@pharma.com

1-888-726-7535

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: October 3, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)