Overview

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