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

Study Overview
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Brief Summary
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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

Official Title
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Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: Idalopirdine (Lu AE58054) 60 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idalopirdine (Lu AE58054) 60 mg (Group A)<br>8 patients with severe renal impairment and not on dialysis | Drug: Idalopirdine (Lu AE58054) 60 mg<br>* encapsulated film-coated tablets for oral use once daily for 10 days<br>|
| Experimental: Idalopirdine (Lu AE58054) 60 mg (Group B)<br>8 healthy subjects | Drug: Idalopirdine (Lu AE58054) 60 mg<br>* encapsulated film-coated tablets for oral use once daily for 10 days<br>|
| Experimental: Idalopirdine (Lu AE58054) 60 mg (Group C)<br>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 | Drug: Idalopirdine (Lu AE58054) 60 mg<br>* encapsulated film-coated tablets for oral use once daily for 10 days<br>|
| Experimental: Idalopirdine (Lu AE58054) 60 mg (Group D)<br>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 | Drug: Idalopirdine (Lu AE58054) 60 mg<br>* encapsulated film-coated tablets for oral use once daily for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24) |  | Day 10 | 
| Maximum observed concentration (Cmax) of Lu AE58054 |  | 0-12 hours day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney impairment