Phase 1
N=13
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
Opioid Overdose
Bottom Line
View on ClinicalTrials.gov: NCT06719986 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir — 4.42; 2.03 L/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nalmefene HCl injection (Drug); Naloxone HCl intranasal (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir |
4.42; 2.03 | — |
| SECONDARY Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir |
2.92; 3.02; 2.00; 1.67; 4.42; 2.03 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
8.3576; 5.6015 | — |
| SECONDARY Area Under the Curve (AUC0-2.5) |
0.0440; 0.256 | — |
| SECONDARY Area Under the Curve (AUC0-5) |
0.2225; 0.1002 | — |
| SECONDARY Area Under the Curve (AUC0-10) |
0.7576; 0.3311 | — |
| SECONDARY Area Under the Curve (AUC0-15) |
1.2716; 0.6300 | — |
| SECONDARY Area Under the Curve (AUC0-20) |
1.7479; 0.9817 | — |
| SECONDARY Area Under the Curve (AUCt) |
23.1620; 13.4803 | — |
| SECONDARY Area Under the Curve (AUCinf) |
25.7412; 13.4938 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
0.2083; 0.6667 | — |
| SECONDARY Time to First Measurable Plasma Concentration (Tlag) |
0.0527; 0.0464 | — |
| SECONDARY Half-life (T1/2) |
7.9754; 1.6353 | — |
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:
- 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.
Key Exclusion Criteria include:
- 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.
Other inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06719986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.