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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07315360
Eligibility Criteria:
Inclusion Criteria:
* Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.
* BMI of 17.5 to 40.0 kg/m2 (inclusive), and a total body weight ≥45 kg (99 lbs).
* Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.
* Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
* Group 1 only: normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from the screening visits.
* Groups 2 \& 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.
* Groups 2 \& 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):
* Severe RI: 15 ≤ mean eGFR \<30 mL/min, not requiring hemodialysis.
* Moderate RI: 30 ≤ mean eGFR \<60 mL/min.
Exclusion Criteria:
* Any condition possibly affecting drug absorption.
* At screening, a positive result for HIV antibodies.
* History of renal, liver, or heart transplantation.
* Urinary incontinence without catheterization.
* Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.
* Use of an investigational product within 30 days or 5 half-lives (whichever longer).
* A positive urine drug test or breath alcohol test at screening or admission to study clinic.
* Group 1 only: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
* Group 1 only: screening ECG demonstrating QTcF interval \>450 ms or a QRS interval \>120 ms.
* Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
* Group 2 \& 3 only: presence of acute renal disease
* Group 2 \& 3 only: requiring dialysis or anticipated need for dialysis
* Group 2 \& 3 only: listed for solid organ transplantation
* Groups 2 \& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.
* Groups 2 \& 3 only: screening ECG demonstrating a QTcF interval \>470 ms or a QRS interval \>120 ms.
* Groups 2 \& 3 only: unstable medical conditions or comorbidities that would interfere with study participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07315360
Study Brief:
Protocol Section:
NCT07315360