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

November 6, 2015 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Idalopirdine (Lu AE58054) 60 mg (Group A)
8 patients with severe renal impairment and not on dialysis
Drug: Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Experimental: Idalopirdine (Lu AE58054) 60 mg (Group B)
8 healthy subjects
Drug: Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Experimental: Idalopirdine (Lu AE58054) 60 mg (Group C)

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
Time Frame: Day 10
Day 10
Maximum observed concentration (Cmax) of Lu AE58054
Time Frame: 0-12 hours day 10
0-12 hours day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14916A
  • 2012-005647-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Idalopirdine (Lu AE58054) 60 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe