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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT04019418
Eligibility Criteria:
Inclusion Criteria:
* Male
* Age between 18-40 years (inclusive)
* Body mass index (BMI) of 18-30 kg/m2
* Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
Exclusion Criteria:
* Abnormal ECG
* Screening blood results outside of normal reference values
* Current smokers
* Current or history of substance abuse and/or excess alcohol intake
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
* Participation in a research study in the 12 week period prior to entering this study.
* Any blood donation within the 12 week period prior to entering this study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04019418
Study Brief:
Protocol Section:
NCT04019418