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Pharmacokinetic Evaluation of Intranasal Nalmefene

Sponsored by Opiant Pharmaceuticals Inc

About this trial

Last updated 2 years ago

Study ID

OPNT003-PK-001

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18 to 55 Years
All Sexes

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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

Exclusion Criteria

* 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