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:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04156035
Eligibility Criteria:
Main Inclusion Criteria:
* From 18 to 45 years of age, inclusive
* Body Mass Index (BMI) between 18.0 and 28.5 kg/m2, inclusive
* Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead ECG
Main Exclusion Criteria:
* Clinically relevant allergy or drug hypersensitivity
* A history of psychiatric or neurologic disorders
* Alcohol or substance dependence within the last 12 months from screening
* A positive urine drug screen at any visit
* MR exclusion criteria, elevated intracranial pressure or glaucoma
* Hypertonia, cardiac insufficiency, myocardial infarct within last 6 months
* Liver or renal function disorder
* Prescription of psychotropic medication within 28 days prior to screening
* Non-prescription medication, including analgesics and supplements such as vitamins and herbal supplements within 48 hours prior to the baseline visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04156035
Study Brief:
Protocol Section:
NCT04156035