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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Heptic Impairment

Treatments: Drug: Lu AE58054 encapsulated film-coated tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231450

15877A

2013-004449-18 (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 Lu AE58054 following a single oral dose of Lu AE58054

Enrollment: 24 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

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

Description:

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

Treatment:

Drug: Lu AE58054 encapsulated film-coated tablets

Patients with moderate hepatic impairment (Group 2)

Experimental group

Description:

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

Treatment:

Drug: Lu AE58054 encapsulated film-coated tablets

Healthy subjects (Group 3)

Experimental group

Description:

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

Treatment:

Drug: Lu AE58054 encapsulated film-coated tablets