CompletedPhase 1

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

Lead sponsor

H. Lundbeck A/S

Asset

Idalopirdine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoints

•AUC of LuAE58054•Cmax of Lu AE58054

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID14916A

Eudract number2012-005647-25

NCT IDNCT02340195

Timeline

Milestones

Study start2015-01 (month precision)

Study first posted2015-01-16estimated

Primary completion2015-09actual (month precision)

Last update posted2015-11-09estimated

Assets

Drug assets

Idalopirdine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

Time frame:Day 10

concentration, descriptive

Primary/protocol endpoint

Maximum observed concentration (Cmax) of Lu AE58054

Time frame:0-12 hours day 10

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.