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

Purdue Pharma

Status and phase: Completed; Phase 1

Conditions: Opioid Overdose

Treatments: Drug: Naloxone HCl intranasal; Drug: Nalmefene HCl injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06719986

NAL1004

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria include:

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

Key Exclusion Criteria include:

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

Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Nalmefene Hydrochloride (HCl) injection

Experimental group

Description:

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Treatment:

Drug: Nalmefene HCl injection

Narcan intranasal

Active Comparator group

Description:

Naloxone 4 mg for intranasal (IN) administration

Treatment:

Drug: Naloxone HCl intranasal