NCT02004587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

November 11, 2013

Last Update Submit

July 10, 2014

Conditions

Hepatic Impairment

Keywords

Hepatic impairmentPharmacokineticsPharmacodynamicsGemigliptin

Outcome Measures

Primary Outcomes (1)

  • AUC

    Blood samples will be prepared at planed points.

    Several time points until 72hr

Study Arms (3)

Mild hepatic impairment group

EXPERIMENTAL

Mild hepatic impairment group by Child-Pugh scores

Drug: Gemigliptin

Moderate hepatic impairment group

EXPERIMENTAL

Moderate hepatic impairment group by Child-Pugh scores

Drug: Gemigliptin

Healthy volunteers

ACTIVE COMPARATOR

Gemigliptin dosing in Healthy subjects

Drug: Gemigliptin

Interventions

GemigliptinDRUG

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

Also known as: Zemiglo
Healthy volunteersMild hepatic impairment groupModerate hepatic impairment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
  • Signed informed consent.
  • White

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Interventions

LC15-0444

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

December 9, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

DE(1)