Phase 1 Nalmefene Pharmacokinetic Study, April 2026
ClinicalTrials.gov Studies
Summary
NIH has registered a Phase 1 pharmacokinetic study on ClinicalTrials.gov evaluating nalmefene 0.5 mg administered via intravenous bolus and intramuscular injection in healthy subjects. The three-arm study includes nalmefene with 0.94% MgCl2 and nalmefene hydrochloride injection. Conditions studied include opioid overdose.
What changed
A new Phase 1 clinical trial registration has been published on ClinicalTrials.gov for a pharmacokinetic evaluation of nalmefene 0.5 mg. The study will characterize PK parameters following IV bolus and IM injections using three formulations in healthy subjects.
Pharmaceutical manufacturers and clinical research organizations conducting early-phase opioid antagonist studies should be aware of this study's design and endpoints, as its results may inform future formulation development or comparative analysis for opioid overdose treatments.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Pharmacokinetic (PK) Evaluation of Intravenous (IV) Nalmefene 0.5 mg (0.94% MgCl2) and Nalmefene Hydrochloride Injection 0.5 mg and Intramuscular (IM) Nalmefene 0.5 mg (0.94% MgCl2)
Phase 1 NCT07543276 Kind: PHASE1 Apr 21, 2026
Abstract
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
Conditions: Opioid Overdose
Interventions: Nalmefene + 0.94% MgCl2, Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
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