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

Sponsor

LG Life Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02004587

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: Gemigliptin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mild hepatic impairment group

Mild hepatic impairment group by Child-Pugh scores

Drug: Gemigliptin

Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.

Other Names:

Zemiglo

Experimental: Moderate hepatic impairment group

Moderate hepatic impairment group by Child-Pugh scores

Drug: Gemigliptin

Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.

Other Names:

Zemiglo

Active Comparator: Healthy volunteers

Gemigliptin dosing in Healthy subjects

Drug: Gemigliptin

Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.

Other Names:

Zemiglo

Outcome Measures

Primary Outcome Measures

AUC [Several time points until 72hr]
Blood samples will be prepared at planed points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services	Kiel	Schleswig-Holstein	Germany	24105

Sponsors and Collaborators

LG Life Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LG Life Sciences

ClinicalTrials.gov Identifier:

NCT02004587

Other Study ID Numbers:

LG-DPCL014

First Posted:

Dec 9, 2013

Last Update Posted:

Jul 14, 2014

Last Verified:

Jul 1, 2014

Keywords provided by LG Life Sciences

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Jul 14, 2014