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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT02340195
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged between 50 and 75 years (inclusive)
* BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
* Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
* Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
* Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
* Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)
Exclusion Criteria:
•The subject has taken disallowed medication \<1 week prior to the first dose of IMP or \<5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)
Other protocol defined inclusion and exclusion criteria do apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT02340195
Study Brief:
Protocol Section:
NCT02340195