Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT04828005
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04828005
Study Brief:
Protocol Section:
NCT04828005