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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04494360
Eligibility Criteria:
Inclusion Criteria:
* No clinically significant abnormality based on medical history, physical exam, and 12-lead electrocardiogram (ECG) collected during Visit 1
* Women must be of non-childbearing potential, defined as either: a.) Postmenopausal or b.) Permanently sterile
* Must be willing to provide a deoxyribonucleic acid (DNA) sample for assessment of genetic variants associated with NAFLD
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion Criteria:
* History or presence of drug abuse within the 2 years prior to Visit 1
* Excessive use of alcohol within 2 years prior to the study
* Body mass index greater than (\>) 40 kilogram per meter square (kg/m\^2)
* Evidence of other active (acute or chronic) liver disease other than NAFLD/ Nonalcoholic steatohepatitis (NASH)
* History of bariatric surgery or planning to undergo bariatric surgery within the next year
* Inability to undergo magnetic resonance imaging (MRI)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04494360
Study Brief:
Protocol Section:
NCT04494360