Pharmacokinetic Evaluation of Intranasal Nalmefene

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID: NCT04759768
Run by: Opiant Pharmaceuticals Inc
People needed: 68
Starts: 2021-02-08
Expected to finish: 2021-05-24
Last updated by the study team: 2024-08-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female aged 18 to 55 years inclusive
BMI ranging from 18 to 30 kg/m2, inclusive
Adequate venous access
Subjects must be non-smokers

You may not qualify if…

History of clinically significant disease
Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
Following an abnormal diet 4 weeks prior to screening
Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
Use of enzyme altering drugs 30 days before intervention
Use of nasal products 28 days before intervention and throughout the study
Previous or current opioid, alcohol, or other drug dependence
Donated or received blood 30 days before intervention
Women who are pregnant or breastfeeding at screening
Women of childbearing potential unless surgically sterile or use effective contraception
Current or recent upper respiratory tract infection
Allergic to nalmefene

Where it is running

Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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