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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT05094934
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive).
* Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to KDIGO 2012:
Group description eGFR (mL/min)
1. Normal renal function more than or equal to 90
2. Mildly decreased renal function 60 - less than 90
3. Moderately decreased renal function 30 - less than 60
4. Severely decreased renal function less than 30 not requiring dialysis
Exclusion Criteria:
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the study doctor.
* Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05094934
Study Brief:
Protocol Section:
NCT05094934