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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-12-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Opioid Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nalmefene Hydrochloride (HCl) injection

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Group Type EXPERIMENTAL

Nalmefene HCl injection

Intervention Type DRUG

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Narcan intranasal

Naloxone 4 mg for intranasal (IN) administration

Group Type ACTIVE_COMPARATOR

Naloxone HCl intranasal

Intervention Type DRUG

Naloxone 4 mg for intranasal (IN) administration

Interventions

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Nalmefene HCl injection

Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration

Intervention Type DRUG

Naloxone HCl intranasal

Naloxone 4 mg for intranasal (IN) administration

Intervention Type DRUG

Other Intervention Names

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Narcan

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes