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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT04419220
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male ≥18 and ≤ 50 years of age.
* Subject is a non-smoker for at least 6 months prior to study start.
* Subject has a body mass index between 18-28 kg/m2.
* Subject is judged to be in good health on the basis of medical history and vital signs.
* Subject understands the procedures and agrees to participate in the study by giving written informed consent.
Exclusion Criteria:
* Subject has a history of any illness which, in the investigator's opinion, might confound the results of the study.
* Subject has burns, scars, flaps or grafts on the abdomen which, in the investigator's opinion, may interfere with the study assessments.
* Subject has an anatomical anomaly of the SMA as evaluated with DUS during screening which, in the investigator's opinion, may interfere with the study assessments.
* Subject currently uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study. Subject has taken 7 days prior to the start of the study any prescription or non-prescription drugs which, in the investigator's opinion, might confound the results of the study.
* Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit or has a history of drug (including alcohol) abuse.
* Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
* Subject has any of the following vital sign measurements at screening: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg.
* Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
* Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04419220
Study Brief:
Protocol Section:
NCT04419220