Drug-drug Interaction Study(Lobeglitazone, Warfarin)

This study is not yet open for participant recruitment.
Verified December 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02002611
First received: November 25, 2013
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lobeglitazone
Drug: Warfarin
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: Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Assess AUC of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess Cmax of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess AUC of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess Cmax of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess AUC of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess Cmax of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess tmax of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess t1/2 of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess CL/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess Vd/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ] [ Designated as safety issue: No ]
  • Assess tmax of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess t1/2 of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess CL/F of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess Vd/F of S-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess tmax of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess t1/2 of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess CL/F of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]
  • Assess Vd/F of R-warfarin [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lobeglitazone
Subjects received Lobeglitazone 0.5 mg daily for 12 days in one period and in the other period, Subjects don't receive Lobeglitazone.
Drug: Lobeglitazone
Experimental: Warfarin
Subjects received Warfarin 25 mg once at period 1 and 2.
Drug: Warfarin

Detailed Description:

From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered.

Group 2 is administered in reverse order.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A healthy male volunteer between 19 and 55 years old.
  • BMI between 19 and 27.
  • Signed the informed consent form prior to study participation.
  • Able to participate in the entire trial

Exclusion Criteria:

  • Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
  • Clinically significant hemorrhagic disease
  • Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
  • Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
  • Participated in the other clinical trials and administrated IP within 60 days prior to screening
  • Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
  • Previously donate whole blood within 60 days or component blood within 30 days
  • sit SBP < 90mmHg or sit SBP ≥ 140mmHg or sit DBP < 60mmHg or sit DBP ≥ 90mmHg
  • A heavy alcohol consumer (alcohol > 140 g/week) or cannot stop drinking
  • A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking
  • A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having
  • Positive for the Triage TOX drug on urine
  • Positive for HIV antibody, HBsAg, HCV antibody test
  • AST, ALT or Total bilirubin > UNL * 1.5
  • Estimated GFR < normal limit
  • INR, aPTT over the normal limit
  • Clinically significant laboratory test result
  • Clinically significant ECG
  • An impossible one who participates in clinical trial by investigator's decision including other reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02002611

Contacts
Contact: Jae Wook Ko, M.D., Ph.D. 82-2-3410-3690 jw0701.ko@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jae Wook Ko, M.D., Ph.D.    82-2-3410-3690    jw0701.ko@samsung.com   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Jae Wook Ko, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02002611     History of Changes
Other Study ID Numbers: 19DDI13016
Study First Received: November 25, 2013
Last Updated: December 1, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Chong Kun Dang Pharmaceutical:
Lobeglitazone
Warfarin
Type 2 Diabetes Mellitus
Drug-Drug interaction
Phase 1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014