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

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ClinicalTrials.gov Identifier: NCT02004587
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

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 Name: 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 Name: 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 Name: Zemiglo




Primary Outcome Measures :
  1. AUC [ Time Frame: Several time points until 72hr ]
    Blood samples will be prepared at planed points.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004587


Locations
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Germany
CRS Clinical Research Services
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
LG Life Sciences

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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02004587     History of Changes
Other Study ID Numbers: LG-DPCL014
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Keywords provided by LG Life Sciences:
Hepatic impairment
Pharmacokinetics
Pharmacodynamics
Gemigliptin

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases