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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Heptic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with mild hepatic impairment (Group1)

8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054

Group Type EXPERIMENTAL

Lu AE58054 encapsulated film-coated tablets

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Lu AE58054 encapsulated film-coated tablets

Intervention Type DRUG

Healthy subjects (Group 3)

8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.

Group Type EXPERIMENTAL

Lu AE58054 encapsulated film-coated tablets

Intervention Type DRUG

Interventions

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Lu AE58054 encapsulated film-coated tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes