Status:
COMPLETED
Pharmacodynamic Evaluation of Intranasal Nalmefene
Lead Sponsor:
Opiant Pharmaceuticals Inc
Conditions:
Pharmacodynamic
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Detailed Description
Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04828005
Start Date
March 30 2021
End Date
March 14 2022
Last Update
July 14 2025
Active Locations (1)
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1
PRA Health Sciences
Salt Lake City, Utah, United States, 84124