Back to resultsPharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Primary Purpose
Heptic Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Lu AE58054 encapsulated film-coated tablets
Sponsored by
About this trial
This is an interventional treatment trial for Heptic Impairment focused on measuring AE58054, Hepatic impairment
Eligibility 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.
Sites / Locations
- APEX GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Patients with mild hepatic impairment (Group1)
Patients with moderate hepatic impairment (Group 2)
Healthy subjects (Group 3)
Arm Description
8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.
8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.
Outcomes
Primary Outcome Measures
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AE58054
Secondary Outcome Measures
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02231450
Brief Title
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Official Title
Interventional, Open-label, Three-group Study to Determine the Pharmacokinetic Properties of Single Oral Dosing of Lu AE58054 in Patients With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heptic Impairment
Keywords
AE58054, Hepatic impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with mild hepatic impairment (Group1)
Arm Type
Experimental
Arm Description
8 patients with mild hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054
Arm Title
Patients with moderate hepatic impairment (Group 2)
Arm Type
Experimental
Arm Description
8 patients with moderate hepatic impairment will be administered a single oral dose of 60 mg Lu AE58054.
Arm Title
Healthy subjects (Group 3)
Arm Type
Experimental
Arm Description
8 healthy subjects will be administered a single oral dose of 60 mg Lu AE58054.
Intervention Type
Drug
Intervention Name(s)
Lu AE58054 encapsulated film-coated tablets
Primary Outcome Measure Information:
Title
Area under the Lu AE58054 plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time Frame
0 to 96 hours
Title
Maximum observed plasma concentration (Cmax) of Lu AE58054
Time Frame
0 to 96 hours
Secondary Outcome Measure Information:
Title
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs, weight, and ECG)
Time Frame
Screening to day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
APEX GmbH
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics Properties of Single Oral Dosing of Lu AE58054 in Subjects With Hepatic Impairment (Mild and Moderate) and in Healthy Subjects
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