A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02167061
First received: June 11, 2014
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: DA-1229_01
Drug: Evogliptin 5 mg + Metformin XR 1000 mg
Drug: DA-1229_01 fast
Drug: DA-1229_01 fed
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, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Area Under Curve(AUC)last of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]
  • Maximum of concentration (Cmax) of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of maximum concentration(Tmax) of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]
  • Terminal half-life(t1/2) of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]
  • Apparent Clearance(CL/F) of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]
  • Area Under Curve(AUC)inf of Evogliptin and Metformin [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]
    AUCinf = AUC last + Clast/λz

  • Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial) [ Time Frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Part 1) DA-1229_01 → E+M
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
Drug: DA-1229_01 Drug: Evogliptin 5 mg + Metformin XR 1000 mg
Experimental: (Part 1) E+M → DA-1229_01
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
Drug: DA-1229_01 Drug: Evogliptin 5 mg + Metformin XR 1000 mg
Experimental: (Part 2) DA-1229_01 fast → DA-1229_01 fed
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
Drug: DA-1229_01 fast Drug: DA-1229_01 fed
Experimental: DA-1229_01 fed → DA-1229_01 fast
DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
Drug: DA-1229_01 fast Drug: DA-1229_01 fed

  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 60-125mg/dL glucose level(at screening)
  • Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

  • Volunteer 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)
  • Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
  • Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 2 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
  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: NCT02167061

Contacts
Contact: Kyung-sang Yu, Ph.d., M.B.A +82-2-2072-1920 ksyu@snu.ac.kr

Locations
Korea, Republic of
Clinical Trial Center, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung-sang Yu Yu, M.D., Ph.d., M.B.A    +82-2-2072-1920    ksyu@snu.ac.kr   
Principal Investigator: Kyung-sang Yu, M.D., Ph.d., M.B.A         
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02167061     History of Changes
Other Study ID Numbers: DA1229_01_BE_I
Study First Received: June 11, 2014
Last Updated: September 29, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014