Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

December 27, 2011 updated by: LG Life Sciences

A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 20 to 45, healthy male subjects(at screening)
  • Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
  • FPG 70-125mg/dL glucose level(at screening)
  • Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

  • Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
  • Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
  • Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
  • Subject who already participated in other trials in 2months
  • Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
  • Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LC15-0444
LC15-0444 50mg qd
Drug: LC15-0444
LC15-0444 50mg qd (8 days once daily)
EXPERIMENTAL: Metformin
Metformin 1000mg bid
Drug: Metformin
Metformin 1000 mg bid (8 days twice daily)
EXPERIMENTAL: LC15-0444+Metformin
LC15-0444 50mg qd +Metformin 1000mg bid
Drug: LC15-0444+Metformin
LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCτ,ss
Time Frame: up to 171h30m
To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
up to 171h30m
Cmax,ss
Time Frame: up to 171h 30m
To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
up to 171h 30m

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: up to 171h30m
to measure Safety and tolerability of the investigational products
up to 171h30m
AUECτ,ss
Time Frame: up to 171h30m
Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity
up to 171h30m
AUEC
Time Frame: up to 171h30m
Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure Active/total GLP-1, glucose, insulin, c-peptide, glucagon.
up to 171h30m

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (ESTIMATE)

August 31, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 27, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-DPCL009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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