Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
Alzheimer Disease
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Kidney impairment
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
Sites / Locations
- DE801
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Idalopirdine (Lu AE58054) 60 mg (Group A)
Idalopirdine (Lu AE58054) 60 mg (Group B)
Idalopirdine (Lu AE58054) 60 mg (Group C)
Idalopirdine (Lu AE58054) 60 mg (Group D)
8 patients with severe renal impairment and not on dialysis
8 healthy subjects
Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with moderate renal impairment
Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B 8 patients with mild renal impairment