Clinical trial NCT02002611: Drug-drug Interaction Study(Lobeglitazone, Warfarin)
Official title: Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Lobeglitazone
Warfarin
Type 2 Diabetes Mellitus
Drug-Drug interaction
Phase 1
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Assess AUC of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess Cmax of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess AUC of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess Cmax of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess AUC of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess Cmax of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
Secondary outcomes:
measure: Assess tmax of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess t1/2 of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess CL/F of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess Vd/F of lobeglitazone
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h
measure: Assess tmax of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess t1/2 of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess CL/F of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess Vd/F of S-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess tmax of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess t1/2 of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess CL/F of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
measure: Assess Vd/F of R-warfarin
timeFrame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Wook Ko, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: