NCT03129347

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Nalmefene	Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-06-09
• Completion: 2017-07-03
• First posted: 2017-04-26
• Last updated: 2018-03-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study