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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Lu AF35700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03189615

17256A

2016-004139-20 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Patients with mild hepatic impairment (Group1)

Experimental group

Treatment:

Drug: Lu AF35700

Patients with moderate hepatic impairment (Group 2)

Experimental group

Treatment:

Drug: Lu AF35700

Healthy subjects (Group 3)

Experimental group

Treatment:

Drug: Lu AF35700