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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Renal Insufficiency Tauopathies Urogenital Diseases Urologic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DE801

München, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Idalopirdine (Lu AE58054) 60 mg

Drug

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

Primary outcomes

Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)

Time frame: Day 10
Maximum observed concentration (Cmax) of Lu AE58054

Time frame: 0-12 hours day 10

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2015
First posted: Jan 16, 2015
Registry last updated: Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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