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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S

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.