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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT05704556
Eligibility Criteria:
Key Inclusion Criteria:
* Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
* Body mass index (BMI) of greater than or equal to (\>=)18.0 to less than (\<) 40.0 kilogram per square meter (kg/m\^2)
* Stable renal function as pre-defined in the protocol
* Cohorts 2 and 4: Matched Healthy Participants
* Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)
Key Exclusion Criteria:
* Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
* Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening
* Cohorts 2 and 4: Matched Healthy Participants
* Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis
* All Cohorts:
* History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
* Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05704556
Study Brief:
Protocol Section:
NCT05704556