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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Idalopirdine (Lu AE58054) 60 mg

• Registration Number: NCT02340195
• Lead Sponsor: H. Lundbeck A/S

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Primary Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Idalopirdine (Lu AE58054) 60 mg (Group A)	Idalopirdine (Lu AE58054) 60 mg	8 patients with severe renal impairment and not on dialysis
Idalopirdine (Lu AE58054) 60 mg (Group C)	Idalopirdine (Lu AE58054) 60 mg	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
Idalopirdine (Lu AE58054) 60 mg (Group D)	Idalopirdine (Lu AE58054) 60 mg	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
Idalopirdine (Lu AE58054) 60 mg (Group B)	Idalopirdine (Lu AE58054) 60 mg	8 healthy subjects

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

DE801; 🇩🇪 Munchen, Germany