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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07450092
Eligibility Criteria:
Inclusion Criteria:
* Age: Participant must be over 18 and under 45 years of age at the time of signing the informed consent.
* Type of Participant and Disease Characteristics: Participants who are overtly healthy as determined by their medical history. The participants will be asked to fill out a health report stating to be healthy, using no relevant medication, and having no relevant allergies or hypersensitivity to the active substances or to any of the excipients of the medications used.
* Weight: BMI under 30 kg/m2
* Sex and Contraceptive/Barrier Requirements: Both male and female participants can be included. Female participants of childbearing potential will be asked to take a pregnancy test to confirm the absence of pregnancy prior to study drug administration on both visit 1 and 2.
* Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
* Drugs: Concomitant use of sedatives, MAO-inhibitors, SSRI, ritonavir, cimetidine, chlorpromazine, phenytoin, erythromycin, itraconazole, platelet inhibitors, Apomorphine, alcohol (during the trial period) or other opioids or opioid antagonists (during the trial period).
* History of drug dependency: Recent head injury (last. 12 months), known increased ICP, seizures or epilepsy
* Other: Known reduced liver- or kidney function, reduced respiratory drive, known supraventricular tachycardia or prolonged QTc, hypertrophy of the prostate or urinary constriction, ongoing pregnancy or breastfeeding. Known acute glaucoma, myasthenia gravis. History of cold injuries or frostbites.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07450092
Study Brief:
Protocol Section:
NCT07450092