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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02340195

Enrollment

Registered

2015-01-16

Start date

2015-01-31

Completion date

Unknown

Last updated

2015-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Kidney impairment

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

Interventions

DRUGIdalopirdine (Lu AE58054) 60 mg

encapsulated film-coated tablets for oral use once daily for 10 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026