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

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004587
• Other study ID #: LG-DPCL014
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2013
• Last updated: July 10, 2014
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	Blood samples will be prepared at planed points.	Several time points until 72hr	No