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 range18 Years – 55 Years

SexALL

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

Maximum Plasma Concentration (Cmax)

Trial details

NCT IDNCT07543276

SponsorPurdue Pharma LP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-03

View on ClinicalTrials.gov More Opioid Overdose trials

Who can participate

Age range18 Years – 55 Years

SexALL

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

Maximum Plasma Concentration (Cmax)