CompletedPhase 1

Pharmacokinetic (PK) Evaluation of Nalmefene Formulations

United States13 participantsStarted 2026-02-06

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Curve (AUC0-2.5)

Timeframe: 2.5 minutes post-dose

Area Under the Curve (AUC0-5)

Timeframe: 5 minutes post-dose

Area Under the Curve (AUC0-10)

Timeframe: 10 minutes post-dose

Area Under the Curve (AUC0-15)

Timeframe: 15 minutes post-dose

Area Under the Curve (AUC0-20)

Timeframe: 20 minutes post-dose

Area Under the Curve (AUC0-30)

Timeframe: 30 minutes post-dose

Area Under the Curve (AUCt)

Timeframe: Up to 48 hours post-dose

Area Under the Curve (AUCinf)

Timeframe: Up to 48 hours post-dose

Trial details

NCT IDNCT07543276

SponsorKnoa Pharma LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-03

View on ClinicalTrials.gov More Opioid Overdose trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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

What they're measuring

Area Under the Curve (AUC0-2.5)

Timeframe: 2.5 minutes post-dose

Area Under the Curve (AUC0-5)

Timeframe: 5 minutes post-dose

Area Under the Curve (AUC0-10)

Timeframe: 10 minutes post-dose

Area Under the Curve (AUC0-15)

Timeframe: 15 minutes post-dose

Area Under the Curve (AUC0-20)

Timeframe: 20 minutes post-dose

Area Under the Curve (AUC0-30)

Timeframe: 30 minutes post-dose

Area Under the Curve (AUCt)

Timeframe: Up to 48 hours post-dose

Area Under the Curve (AUCinf)

Timeframe: Up to 48 hours post-dose