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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01426399
First received: August 22, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: LC15-0444
Drug: Metformin
Drug: LC15-0444+Metformin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • AUCτ,ss [ Time Frame: up to 171h30m ] [ Designated as safety issue: No ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444

  • Cmax,ss [ Time Frame: up to 171h 30m ] [ Designated as safety issue: No ]
    To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444


Secondary Outcome Measures:
  • Vital signs [ Time Frame: up to 171h30m ] [ Designated as safety issue: Yes ]
    to measure Safety and tolerability of the investigational products

  • AUECτ,ss [ Time Frame: up to 171h30m ] [ Designated as safety issue: No ]
    Compare the pharmacodynamic interaction between LC15-0444 and metformin in healthy male subjects This parameter is been used to measure DPP4 activity

  • AUEC [ Time Frame: up to 171h30m ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426399

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Kyung-sang Yu, M.D,Ph.D Seoul national univ. hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01426399     History of Changes
Other Study ID Numbers: LG-DPCL009
Study First Received: August 22, 2011
Last Updated: December 27, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014