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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT04004195
Eligibility Criteria:
Inclusion Criteria:
* Participant must be ≥18 years of age
* The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).
* Race: White
* BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m\*2 at the first screening visit.
* Male or female.
* Participants with renal impairment must have an eGFR (estimated glomerular filtration rate) \<90 mL/min/1.73 m\*2 determined from serum creatinine 21-3 days prior to dosing using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation (eGFR has to be repeated if screening period \>10 days before dosing).
Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.
Exclusion Criteria:
* Clinically relevant findings in the physical examination affecting the objectives of the study.
* Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:
* Moderate and strong inhibitors of CYP3A;
* Moderate and strong CYP3A inducers;
* Moderate and strong inhibitors of P-gp transport;
* UDP-glucuronosyltransferase (UGT) inhibitors probenecid and valproic acid.
* Regular daily consumption of more than 10 cigarettes.
* Acute renal failure.
* Active nephritis.
* Impairment of any other major organ system other than the kidney.
* Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04004195
Study Brief:
Protocol Section:
NCT04004195