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Completed

NCT Number: NCT07543276

Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.

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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:

  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range [18.0-30.0] kg/m2 (inclusive).
  • Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions.

Key Exclusion criteria:

  • Females who are pregnant or lactating.
  • Current or recent (within 5 years) history of drug or alcohol abuse.
  • History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
  • Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride.
  • Dosing in a clinical drug study during the 30 days preceding the initial dose in this study.
  • Any significant illness during the 30 days preceding the initial dose in this study

Other inclusion/exclusion criteria may apply.

Treatment and study plan

Nalmefene + 0.94% MgCl2

Drug

Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration

Nalmefene Hydrochloride Injection

Drug

Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration

Primary outcomes

  1. Area Under the Curve (AUC0-2.5)

    Time frame: 2.5 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  2. Area Under the Curve (AUC0-5)

    Time frame: 5 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  3. Area Under the Curve (AUC0-10)

    Time frame: 10 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  4. Area Under the Curve (AUC0-15)

    Time frame: 15 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  5. Area Under the Curve (AUC0-20)

    Time frame: 20 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  6. Area Under the Curve (AUC0-30)

    Time frame: 30 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  7. Area Under the Curve (AUCt)

    Time frame: Up to 48 hours post-dose

    Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  8. Area Under the Curve (AUCinf)

    Time frame: Up to 48 hours post-dose

    Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  9. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 48 hours post-dose

    Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration

  10. Area Under the Curve (AUC0-2.5)

    Time frame: 2.5 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  11. Area Under the Curve (AUC0-5)

    Time frame: 5 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  12. Area Under the Curve (AUC0-10)

    Time frame: 10 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  13. Area Under the Curve (AUC0-15)

    Time frame: 15 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  14. Area Under the Curve (AUC0-20)

    Time frame: 20 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  15. Area Under the Curve (AUC0-30)

    Time frame: 30 minutes post-dose

    Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  16. Area Under the Curve (AUCt)

    Time frame: Up to 48 hours post-dose

    Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  17. Area Under the Curve (AUCinf)

    Time frame: Up to 48 hours post-dose

    Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

  18. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 48 hours post-dose

    Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration

Sponsors and collaborators

Lead sponsor

Knoa Pharma LLC

Industry

Collaborators

  • Purdue Pharma LP

Registry information

Official study title

A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Jun 5, 2026

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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