Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects

The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700

Completed

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Key information

Conditions

Hepatic Impairment

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX

Munich, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)

Exclusion criteria

Subjects previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Treatment and study plan

Lu AF35700

Drug

Single oral dose of 10 mg Lu AF35700

Primary outcomes

Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)

Time frame: Predose to day 57 postdose

Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AF35700

Time frame: Predose to day 57 postdose

Maximum observed plasma concentration (Cmax) of Lu AF35700

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jun 16, 2017
Registry last updated: May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed