Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-07-03

Brief Summary

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

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Detailed Description

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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

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nalmefene (high dose)

Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period

Group Type EXPERIMENTAL