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

LG Life Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Gemigliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02004587

LG-DPCL014

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

28 participants in 3 patient groups

Mild hepatic impairment group

Experimental group

Description:

Mild hepatic impairment group by Child-Pugh scores

Treatment:

Drug: Gemigliptin

Moderate hepatic impairment group

Experimental group

Description:

Moderate hepatic impairment group by Child-Pugh scores

Treatment:

Drug: Gemigliptin

Healthy volunteers

Active Comparator group

Description:

Gemigliptin dosing in Healthy subjects

Treatment:

Drug: Gemigliptin