Pharmacokinetic Evaluation of Intranasal Nalmefene

Phase 1 Completed 68 enrolled Opiant Pharmaceuticals Inc

RandomizedCrossoverOpen-labelBasic science

Summary

This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.

Timeline

Start: 2021-02-08
Primary completion: 2021-05-17
Completion: 2021-05-24

Publications

Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic Properties of an FDA-approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose. Clin Pharmacol Drug Dev. 2024 Jan;13(1):58-69. doi: 10.1002/cpdd.1312. Epub 2023 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalmefene	Small molecule	1 mg	Intranasal
Subject	Nalmefene	Small molecule	3 mg	Intranasal

Indications

No indication recorded.