Clinical trial NCT06719986: Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
Official title: A Study to Characterize the Time Course of Reversal of Opioid (Fentanyl)-Induced Respiratory Depression Following Administration of Nalmefene Autoinjector 1.5 mg (0.94% MgCl2) Intramuscular and Narcan® 4 mg Intranasal in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Overdose
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Change in Minute Ventilation 5 minutes from opioid induced nadir
timeFrame: 5 minutes after opioid antagonist administration
Secondary outcomes:
measure: Change in Minute Ventilation at 2.5, 10, 15, 20, and 90 minutes from opioid induced nadir
timeFrame: 2.5, 10, 15, 20, and 90 minutes after opioid antagonist administration
measure: Maximum Plasma Concentration (Cmax)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUC0-2.5)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUC0-5)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUC0-10)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUC0-15)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUC0-20)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUCt)
timeFrame: up to 24 hours post-dose
measure: Area Under the Curve (AUCinf)
timeFrame: up to 24 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: up to 24 hours post-dose
measure: Time to first measurable plasma concentration (Tlag)
timeFrame: up to 24 hours post-dose
measure: Half-life (T1/2)
timeFrame: up to 24 hours post-dose
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio Clinical Trials
state: Ohio
Study officials:
References: