Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Phase 1
Completed
- Conditions
- Heptic Impairment
- Interventions
- Drug: Lu AE58054 encapsulated film-coated tablets
- Registration Number
- NCT02231450
- Lead Sponsor
- H. Lundbeck A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy subjects (Group 3) Lu AE58054 encapsulated film-coated tablets 8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054. Patients with moderate hepatic impairment (Group 2) Lu AE58054 encapsulated film-coated tablets 8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054. Patients with mild hepatic impairment (Group1) Lu AE58054 encapsulated film-coated tablets 8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
- Primary Outcome Measures
Name Time Method Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf) 0 to 96 hours Maximum observed plasma concentration (Cmax) of Lu AE58054 0 to 96 hours
- Secondary Outcome Measures
Name Time Method Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG) Screening to day 11
Trial Locations
- Locations (1)
APEX GmbH
🇩🇪Munich, Germany