Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S

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