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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06723535
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
* Severe Renal Impaired Participants:
1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.
2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.
3. Participant must be medically stable for at least 1 month before study intervention administration.
* Participants with ESRD:
1. Participant has ESRD as defined by an eGFR \< 15 mL/min at screening.
2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
3. Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.
* Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
* Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).
Exclusion Criteria:
* Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
* Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
* Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
* Other protocol defined inclusion/exclusion criteria apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
84 Years
Study:
NCT06723535
Study Brief:
Protocol Section:
NCT06723535