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

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: Healthy
• Intervention / Treatment: Drug: LC15-0444; Drug: Metformin; Drug: LC15-0444+Metformin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444	up to 171h30m
Cmax,ss	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	to measure Safety and tolerability of the investigational products	up to 171h30m
AUECτ,ss	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	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

• Sponsor: LG Life Sciences

Publications and helpful links

General Publications

• Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3.

Study record dates

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: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: LG-DPCL009