NCT02002611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 3, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

November 25, 2013

Last Update Submit

July 1, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

LobeglitazoneWarfarinType 2 Diabetes MellitusDrug-Drug interactionPhase 1

Outcome Measures

Primary Outcomes (6)

  • Assess AUC of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess Cmax of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess AUC of S-warfarin

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  • Assess Cmax of S-warfarin

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  • Assess AUC of R-warfarin

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  • Assess Cmax of R-warfarin

    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 (12)

  • Assess tmax of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess t1/2 of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess CL/F of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess Vd/F of lobeglitazone

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h

  • Assess tmax of S-warfarin

    0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h

  • +7 more secondary outcomes

Study Arms (2)

Lobeglitazone

EXPERIMENTAL

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

Warfarin

EXPERIMENTAL

Subjects received Warfarin 25 mg once at period 1 and 2.

Drug: Warfarin

Interventions

LobeglitazoneDRUG
Lobeglitazone
WarfarinDRUG
Warfarin

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazoneWarfarin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jae Wook Ko, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 6, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

July 3, 2014

Record last verified: 2014-07

Locations

KR(1)