Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: Gemigliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment group<br>Mild hepatic impairment group by Child-Pugh scores | Drug: Gemigliptin<br>* Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.<br>* Other names: Zemiglo;|
| Experimental: Moderate hepatic impairment group<br>Moderate hepatic impairment group by Child-Pugh scores | Drug: Gemigliptin<br>* Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.<br>* Other names: Zemiglo;|
| Active Comparator: Healthy volunteers<br>Gemigliptin dosing in Healthy subjects | Drug: Gemigliptin<br>* Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.<br>* Other names: Zemiglo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Blood samples will be prepared at planed points. | Several time points until 72hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin