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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02231450

Enrollment

Registered

2014-09-04

Start date

2014-07-31

Completion date

Unknown

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heptic Impairment

Keywords

AE58054, Hepatic impairment

Brief summary

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

Interventions

DRUGLu AE58054 encapsulated film-coated tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026