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

H. Lundbeck A/S24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Impairment

Interventions

Lu AF35700DRUG

Single oral dose of 10 mg Lu AF35700

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

APEX

Munich, Germany

Outcomes

Primary Outcomes

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

Time frame: Predose to day 57 postdose

Maximum observed plasma concentration (Cmax) of Lu AF35700

Time frame: Predose to day 57 postdose

Data from ClinicalTrials.gov

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