Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects

March 17, 2015 updated by: H. Lundbeck A/S

Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects

The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of Lu AE58054 following a single oral dose of Lu AE58054

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • Germany
      • Munich, Germany
        • Apex Gmbh

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 40 and 65 years (inclusive) with a body mass index between 19 and 32 kg/m2 (inclusive).
  • Group 1: Patients with mild hepatic impairment (Child-Pugh's Criteria A, score 5-6)
  • Group 2: Patients with moderate hepatic impairment (Child-Pugh's Criteria B, score 7-9)
  • Group 3: Healthy subjects with normal hepatic function

Other pre-defined inclusion and exclusion criteria may 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: Patients with mild hepatic impairment (Group1)
8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
Drug: Lu AE58054 encapsulated film-coated tablets
Experimental: Patients with moderate hepatic impairment (Group 2)
8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.
Drug: Lu AE58054 encapsulated film-coated tablets
Experimental: Healthy subjects (Group 3)
8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.
Drug: Lu AE58054 encapsulated film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time Frame: 0 to 96 hours
0 to 96 hours
Maximum observed plasma concentration (Cmax) of Lu AE58054
Time Frame: 0 to 96 hours
0 to 96 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
Time Frame: Screening to day 11
Screening to day 11

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

July 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15877A
  • 2013-004449-18 (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.

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