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Drug-drug Interaction Study(Lobeglitazone, Warfarin)

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ClinicalTrials.gov Identifier: NCT02002611
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Lobeglitazone Drug: Warfarin Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Assess AUC of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  2. Assess Cmax of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. Assess tmax of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  2. Assess t1/2 of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  3. Assess CL/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  4. Assess Vd/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002611


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Jae Wook Ko, Ph.D Samsung Medical Center
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02002611     History of Changes
Other Study ID Numbers: 19DDI13016
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014
Keywords provided by Chong Kun Dang Pharmaceutical:
Lobeglitazone
Warfarin
Type 2 Diabetes Mellitus
Drug-Drug interaction
Phase 1
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Warfarin
Anticoagulants