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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Idalopirdine (Lu AE58054) 60 mg

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Kidney impairment

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

DE801

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Idalopirdine (Lu AE58054) 60 mg (Group A)

Idalopirdine (Lu AE58054) 60 mg (Group B)

Idalopirdine (Lu AE58054) 60 mg (Group C)

Idalopirdine (Lu AE58054) 60 mg (Group D)

Arm Description

8 patients with severe renal impairment and not on dialysis

8 healthy subjects

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

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

Outcomes

Primary Outcome Measures

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

Maximum observed concentration (Cmax) of Lu AE58054

Secondary Outcome Measures

Full Information

NCT ID

NCT02340195

First Posted

January 13, 2015

Last Updated

November 6, 2015

Sponsor

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT02340195

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

Kidney impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Idalopirdine (Lu AE58054) 60 mg (Group A)

Arm Type

Experimental

Arm Description

8 patients with severe renal impairment and not on dialysis

Arm Title

Idalopirdine (Lu AE58054) 60 mg (Group B)

Arm Type

Experimental

Arm Description

8 healthy subjects

Arm Title

Idalopirdine (Lu AE58054) 60 mg (Group C)

Arm Type

Experimental

Arm Description

Arm Title

Idalopirdine (Lu AE58054) 60 mg (Group D)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Idalopirdine (Lu AE58054) 60 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Day 10

Title

Maximum observed concentration (Cmax) of Lu AE58054

Time Frame

0-12 hours day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

DE801

City

Munchen

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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