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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05015894
Eligibility Criteria:
Inclusion Criteria:
* Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive)
* Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
* For participants with normal renal function: eGFR of equal to or greater than 90 mL/min
* For participants with mild renal impairment: eGFR of 60-89 mL/min
* For participants with moderate renal impairment: eGFR of 30-59 mL/min
* For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
* For participants with kidney failure: eGFR of less than 15 mL/min or requiring dialysis treatment
Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:
\* Current treatment with haemodialysis
Exclusion Criteria:
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening.
* Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim and cibenzoline 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, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05015894
Study Brief:
Protocol Section:
NCT05015894