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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by LG Life Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014