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:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT05541159
Eligibility Criteria:
Inclusion Criteria:
All participants Participants must weigh at least 50 kg and no more than 120 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, for healthy participants. Must be a non-smoker or and agree to remain a non-smoker from screening until the End of Study.
Group 1
•eGFR as determined by Chronic Kidney Disease Epidemiology Collaboration \[CKD EPI\] equation and conversion within normal range as determined by GFR 90 mL/min at screening and baseline.
Groups 2 to 4
* Participants with different levels of impaired renal function satisfying criteria for renal impairment as determined at screening by the eGFR at screening
* Participants must have documented stable renal disease without evidence of renal progressive disease
Exclusion Criteria:
All Participants
* Use of drugs (prescription, non-prescription and herbal remedies such as St John's wort), within 4 weeks prior to dosing until completion of the End of Study Visit.
* Participant has received a renal transplant at any time in the past and is on immunosuppressant therapy Left ventricular ejection fraction (LVEF) \< 50% or below the institutional standard lower limit, at screening or baseline.
* Uncontrolled hypertension despite medical treatment at screening or baseline. Group 1
* Significant illness, which has not been resolved within 2 weeks prior to dosing of study treatment.
* History or presence of renal disease or kidney injury Groups 2, 3 and 4
* Severe albuminuria
* Other laboratory values grade 2 severity according to NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE)
* Participants undergoing any method of dialysis.
* Participants with renal impairment due to hepatic disease (hepatorenal syndrome).
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05541159
Study Brief:
Protocol Section:
NCT05541159