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CompletedNCT07543276Updated Jun 5, 2026

Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

A Phase 1 interventional study of Nalmefene + 0.94% MgCl2 and Nalmefene + 0.94% MgCl2 in Opioid Overdose, sponsored by Knoa Pharma LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Knoa Pharma LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Opioid Overdose

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03

In context

Opiate Overdose

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's enrollment of 13 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.

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Lead sponsor

Knoa Pharma LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion criteria:

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

Key Exclusion criteria:

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

Other inclusion/exclusion criteria may apply.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Treatment A

    Nalmefene + 0.94% MgCl2 (IV)

    Drug: Nalmefene + 0.94% MgCl2

  • Experimental
    Treatment B

    Nalmefene + 0.94% MgCl2 (IM)

    Drug: Nalmefene + 0.94% MgCl2

  • Active comparator
    Treatment C

    Nalmefene Hydrochloride injection

    Drug: Nalmefene Hydrochloride Injection

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2.5 minutes post-dose

  2. 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

    Time frame: 5 minutes post-dose

  3. 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

    Time frame: 10 minutes post-dose

  4. 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

    Time frame: 15 minutes post-dose

  5. 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

    Time frame: 20 minutes post-dose

  6. 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

    Time frame: 30 minutes post-dose

  7. 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

    Time frame: Up to 48 hours post-dose

  8. 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

    Time frame: Up to 48 hours post-dose

  9. 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

    Time frame: Up to 48 hours post-dose

  10. 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

    Time frame: 2.5 minutes post-dose

  11. 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

    Time frame: 5 minutes post-dose

  12. 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

    Time frame: 10 minutes post-dose

  13. 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

    Time frame: 15 minutes post-dose

  14. 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

    Time frame: 20 minutes post-dose

  15. 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

    Time frame: 30 minutes post-dose

  16. 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

    Time frame: Up to 48 hours post-dose

  17. 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

    Time frame: Up to 48 hours post-dose

  18. 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

    Time frame: Up to 48 hours post-dose

07

Study locations

1 site
  • Ohio Clinical Trials
    Columbus, Ohio 43212, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2026 to primary completion in Apr 2026, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2026
First posted
Apr 21, 2026
StartActual
Feb 6, 2026
Primary completionActual
Apr 3, 2026
CompletionActual
Apr 3, 2026
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07543276
Lead sponsor
Knoa Pharma LLC
Collaborators
Purdue Pharma LP
Responsible party
Sponsor
First posted
Apr 21, 2026
Start date
Feb 6, 2026
Primary completion
Apr 3, 2026
Completion
Apr 3, 2026
Last update
Jun 5, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Nalmefene · Magnesium Chloride

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