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

Alzheimer Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340195
• Other study ID #: 14916A
• Secondary ID: 2012-005647-25
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2015
• Last updated: November 6, 2015
• Start date: January 2015

Study information

• Verified date: November 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days

Locations

Country	Name	City	State
Germany	DE801	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)		Day 10	No
Primary	Maximum observed concentration (Cmax) of Lu AE58054		0-12 hours day 10	No