Status:
COMPLETED
Pharmacokinetic Evaluation of Intranasal Nalmefene
Lead Sponsor:
Opiant Pharmaceuticals Inc
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 nal...
Detailed Description
Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04759768
Start Date
February 8 2021
End Date
May 24 2021
Last Update
August 13 2024
Active Locations (1)
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1
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217