At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Nalmefene HCl injection +1 moredrug
Likely dose
Nalmefene HCl injection 1.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Nalmefene HCl injection and Naloxone HCl intranasal for Opioid Overdose. Completed, enrolled 24 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Overdose
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartOct 2022
Primary CompletionDec 2022
First PostedDec 2024
TodayJul 2026
First PostedDec 6, 2024
Enrollment StartOct 3, 2022
Primary CompletionDec 23, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.6 years ago
Interventions
Nalmefene HCl injectiondrug
Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
Naloxone HCl intranasaldrug
Naloxone 4 mg for intranasal (IN) administration