Status:
COMPLETED
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Heptic Impairment
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02231450
Start Date
July 1 2014
Last Update
March 18 2015
Active Locations (1)
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1
APEX GmbH
Munich, Germany