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

NCT ID: NCT02004587

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-07-31

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild hepatic impairment group

Mild hepatic impairment group by Child-Pugh scores

Group Type: EXPERIMENTAL

Gemigliptin

Intervention Type: DRUG

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

Moderate hepatic impairment group

Moderate hepatic impairment group by Child-Pugh scores

Group Type: EXPERIMENTAL

Gemigliptin

Intervention Type: DRUG

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

Healthy volunteers

Gemigliptin dosing in Healthy subjects

Group Type: ACTIVE_COMPARATOR

Gemigliptin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zemiglo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CRS Clinical Research Services

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

LG-DPCL014

Identifier Type: -

Identifier Source: org_study_id