Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

• Status: Completed
• Trial end date: 2021-11-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to evaluate the safety and tolerability of nalmefene IN.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Opiant Pharmaceuticals Inc
• Treatments: Nalmefene

Criteria

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

• Male subjects of childbearing potential that do not agree to use effective contraception

• Male subjects who plan to donate sperm or have female partner(s) who are pregnant, lactating or planning to attempt to become pregnant

• Current or recent upper respiratory tract infection

• Allergic to nalmefene