Back to resultsStudy Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Lu AF35700
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
- Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)
Exclusion Criteria:
- Subjects previously been dosed with Lu AF35700
Other protocol defined inclusion and exclusion criteria may apply
Sites / Locations
- APEX
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
Outcomes
Primary Outcome Measures
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Maximum observed plasma concentration (Cmax) of Lu AF35700
Maximum observed plasma concentration (Cmax) of Lu AF35700
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189615
Brief Title
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
Official Title
Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 14, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
April 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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 a single oral dose of Lu AF35700
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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 Title
Patients with moderate hepatic impairment (Group 2)
Arm Type
Experimental
Arm Title
Healthy subjects (Group 3)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Description
Single oral dose of 10 mg Lu AF35700
Primary Outcome Measure Information:
Title
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Description
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time Frame
Predose to day 57 postdose
Title
Maximum observed plasma concentration (Cmax) of Lu AF35700
Description
Maximum observed plasma concentration (Cmax) of Lu AF35700
Time Frame
Predose to day 57 postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)
Exclusion Criteria:
Subjects previously been dosed with Lu AF35700
Other protocol 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
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
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