Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Opioid-Related Disorders Clinical Trial

Official title: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Status Completed

Clinical Trial Summary

This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Clinical Trial Description

This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders

• NCT number: NCT03129347
• Study type: Interventional
• Source: National Institute on Drug Abuse (NIDA)
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2017
• Completion date: July 3, 2017