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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Idalopirdine (Lu AE58054) 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02340195

2012-005647-25 (EudraCT Number)

14916A

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Idalopirdine (Lu AE58054) 60 mg (Group A)

Experimental group

Description:

8 patients with severe renal impairment and not on dialysis

Treatment:

Drug: Idalopirdine (Lu AE58054) 60 mg

Idalopirdine (Lu AE58054) 60 mg (Group B)

Experimental group

Description:

8 healthy subjects

Treatment:

Drug: Idalopirdine (Lu AE58054) 60 mg

Idalopirdine (Lu AE58054) 60 mg (Group C)

Experimental group

Description:

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

Treatment:

Drug: Idalopirdine (Lu AE58054) 60 mg

Idalopirdine (Lu AE58054) 60 mg (Group D)

Experimental group

Description:

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

Treatment:

Drug: Idalopirdine (Lu AE58054) 60 mg