NCT07543276

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 15, 2026

Last Update Submit

April 21, 2026

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (18)

  • Area Under the Curve (AUC0-2.5)

    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

    2.5 minutes post-dose

  • Area Under the Curve (AUC0-5)

    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

    5 minutes post-dose

  • Area Under the Curve (AUC0-10)

    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

    10 minutes post-dose

  • Area Under the Curve (AUC0-15)

    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

    15 minutes post-dose

  • Area Under the Curve (AUC0-20)

    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

    20 minutes post-dose

  • Area Under the Curve (AUC0-30)

    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

    30 minutes post-dose

  • Area Under the Curve (AUCt)

    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

    Up to 48 hours post-dose

  • Area Under the Curve (AUCinf)

    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

    Up to 48 hours post-dose

  • Maximum Plasma Concentration (Cmax)

    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

    Up to 48 hours post-dose

  • Area Under the Curve (AUC0-2.5)

    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

    2.5 minutes post-dose

  • Area Under the Curve (AUC0-5)

    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

    5 minutes post-dose

  • Area Under the Curve (AUC0-10)

    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

    10 minutes post-dose

  • Area Under the Curve (AUC0-15)

    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

    15 minutes post-dose

  • Area Under the Curve (AUC0-20)

    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

    20 minutes post-dose

  • Area Under the Curve (AUC0-30)

    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

    30 minutes post-dose

  • Area Under the Curve (AUCt)

    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

    Up to 48 hours post-dose

  • Area Under the Curve (AUCinf)

    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

    Up to 48 hours post-dose

  • Maximum Plasma Concentration (Cmax)

    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

    Up to 48 hours post-dose

Study Arms (3)

Treatment A

EXPERIMENTAL

Nalmefene + 0.94% MgCl2 (IV)

Drug: Nalmefene + 0.94% MgCl2

Treatment B

EXPERIMENTAL

Nalmefene + 0.94% MgCl2 (IM)

Drug: Nalmefene + 0.94% MgCl2

Treatment C

ACTIVE COMPARATOR

Nalmefene Hydrochloride injection

Drug: Nalmefene Hydrochloride Injection

Interventions

Nalmefene + 0.94% MgCl2DRUG

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

Treatment A
Nalmefene Hydrochloride InjectionDRUG

Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration

Treatment C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio Clinical Trials

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Opiate Overdose

Interventions

nalmefeneMagnesium Chloride

Condition Hierarchy (Ancestors)

Drug OverdosePrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersOpioid-Related DisordersNarcotic-Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsMagnesium Compounds

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

April 15, 2026

First Posted

April 21, 2026

Study Start

February 6, 2026

Primary Completion

April 3, 2026

Study Completion

April 3, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

US(1)