CompletedPhase 1

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

United States24 participantsStarted 2022-10-03

Plain-language summary

The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
✓. Body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (BMI) within the range \[18-30\] kg/m2 (inclusive).
✓. Willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable.

Exclusion criteria

✕. Females who are pregnant or lactating.
✕. Any significant illness during the 30 days preceding the initial dose in this study.
✕. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
✕. Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
✕. Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit.
✕. Difficulty with venous access or unsuitable for or unwilling to undergo catheter insertion.

What they're measuring

Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir

Timeframe: 5 minutes after opioid antagonist administration

Trial details

NCT IDNCT06719986

SponsorPurdue Pharma LP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-23

Results submitted2025-03-11

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