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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05386758
Eligibility Criteria:
Inclusion Criteria:
The key Inclusion Criteria include but are not limited to the following:
* Body mass index (BMI) ≥18.5 kg/m\^2 and ≤35 kg/m\^2
* Healthy participants: Baseline estimated glomerular filtration rate (eGFR) ≥90 mL/min based on the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine equation
* Severe renal impairment participants: Baseline estimated glomerular filtration rate (eGFR) \<30 mL/min based on the 2021 CKD-EPI Creatinine equation
Exclusion Criteria:
The key Exclusion Criteria include but are not limited to the following:
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
* History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
Severe renal impairment participants:
* History or presence of renal artery stenosis
* Had a renal transplant
* Currently taking medications to treat chronic medical conditions associated with renal disease if participant has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of medication(s) within 4 hours prior to and 8 hours after administration of the study drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05386758
Study Brief:
Protocol Section:
NCT05386758