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OpenTrials
Completed

NCT Number: NCT06719986

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

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).

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria include:

  • 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.

Key Exclusion Criteria include:

  • 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.

Other inclusion/exclusion criteria may apply.

Treatment and study plan

Nalmefene HCl injection

Drug

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Naloxone HCl intranasal

Drug

Naloxone 4 mg for intranasal (IN) administration

Other names: Narcan

Primary outcomes

  1. Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir

    Time frame: 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 outcomes

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

    Time frame: Baseline, 2.5, 5, 10, 15, 20, 30, 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.

  2. Maximum Plasma Concentration (Cmax)

    Time frame: up to 24 hours post-dose

    Maximum plasma concentration of nalmefene and naloxone.

  3. Area Under the Curve (AUC0-2.5)

    Time frame: 2.5 minutes post-dose

    Area under the plasma concentration-time curve from time zero to 2.5 minutes

  4. Area Under the Curve (AUC0-5)

    Time frame: 5 minutes post-dose

    Area under the plasma concentration-time curve from time zero to 5 minutes

  5. Area Under the Curve (AUC0-10)

    Time frame: 10 minutes post-dose

    Area under the plasma concentration-time curve from time zero to 10 minutes

  6. Area Under the Curve (AUC0-15)

    Time frame: 15 minutes post-dose

    Area under the plasma concentration-time curve from time zero to 15 minutes

  7. Area Under the Curve (AUC0-20)

    Time frame: 20 minutes post-dose

    Area under the plasma concentration-time curve from time zero to 20 minutes

  8. Area Under the Curve (AUCt)

    Time frame: up to 24 hours post-dose

    Area under the plasma concentration-time curve from time zero to the time of last measurable concentration.

  9. Area Under the Curve (AUCinf)

    Time frame: up to 24 hours post-dose

    Area under the plasma concentration-time curve from time zero to infinity.

  10. Time to Maximum Plasma Concentration (Tmax)

    Time frame: up to 24 hours post-dose

    Time to maximum plasma concentration of nalmefene and naloxone.

  11. Time to First Measurable Plasma Concentration (Tlag)

    Time frame: up to 24 hours post-dose

    Time to first measurable plasma concentration of nalmefene and naloxone.

  12. Half-life (T1/2)

    Time frame: up to 24 hours post-dose

    Half life of nalmefene and naloxone.

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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