Back to resultsInfluence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Gemigliptin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
- Signed informed consent.
- White
Exclusion Criteria:
- Unwilling or unable to give informed consent.
- As a result of the medical screening process, a study physician considers the subject unfit for the study.
- The subject has a history of drug or other allergy which contraindicated study participation.
- Female subjects who are pregnant or lactating.
- Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
Sites / Locations
- CRS Clinical Research Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Mild hepatic impairment group
Moderate hepatic impairment group
Healthy volunteers
Arm Description
Mild hepatic impairment group by Child-Pugh scores
Moderate hepatic impairment group by Child-Pugh scores
Gemigliptin dosing in Healthy subjects
Outcomes
Primary Outcome Measures
AUC
Blood samples will be prepared at planed points.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02004587
Brief Title
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
Official Title
A Single-center, Open-label Trial, Investigating the Pharmacokinetics, Pharmacodynamics and the Safety Profile After a Single Oral Dose of Gemigliptin (Investigational Product) in Healthy Subjects and Subjects With Mild or Moderate Hepatic Impairment and After Multiple Oral Dose in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mild hepatic impairment group
Arm Type
Experimental
Arm Description
Mild hepatic impairment group by Child-Pugh scores
Arm Title
Moderate hepatic impairment group
Arm Type
Experimental
Arm Description
Moderate hepatic impairment group by Child-Pugh scores
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Gemigliptin dosing in Healthy subjects
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Other Intervention Name(s)
Zemiglo
Intervention Description
Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.
Primary Outcome Measure Information:
Title
AUC
Description
Blood samples will be prepared at planed points.
Time Frame
Several time points until 72hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
Signed informed consent.
White
Exclusion Criteria:
Unwilling or unable to give informed consent.
As a result of the medical screening process, a study physician considers the subject unfit for the study.
The subject has a history of drug or other allergy which contraindicated study participation.
Female subjects who are pregnant or lactating.
Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
Facility Information:
Facility Name
CRS Clinical Research Services
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
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