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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02004587

Enrollment

Registered

2013-12-09

Start date

2013-09-30

Completion date

2014-07-31

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic impairment, Pharmacokinetics, Pharmacodynamics, Gemigliptin

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.

Interventions

DRUGGemigliptin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
AUC	Several time points until 72hr	Blood samples will be prepared at planed points.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026