Pharmacodynamic Evaluation of Intranasal Nalmefene

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.

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

Details

• Lead Sponsor: Opiant Pharmaceuticals Inc
• Treatments: Nalmefene; Naloxone

Criteria

Inclusion Criteria:

• Male or female aged 18 to 55 years inclusive

• BMI ranging from 18 to 32 kg/m2, inclusive

• Adequate venous access

• Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening

Exclusion Criteria:

• History of clinically significant disease

• Significant trauma injury, major surgery, open biopsy within 30 days prior to screening

• Subject who has a difficult airway for intubation.

• 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 or naloxone or known hypersensitivity reaction to plastics.