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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT06559527
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
* Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
* Normal renal function - greater than or equal to 90 mL/min
* Mild renal impairment - 60 - 89 (mL/min)
* Moderate renal impairment - 30 - 59 (mL/min)
* Severe renal impairment - less than 30 (mL/min) not requiring dialysis
* End-stage renal disease (ESRD) - Requiring dialysis treatment
* For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.
Exclusion Criteria:
* Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
* Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP).
* Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06559527
Study Brief:
Protocol Section:
NCT06559527