NCT01872780

Brief Summary

The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2008

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

6 months

First QC Date

December 6, 2011

Last Update Submit

June 5, 2013

Conditions

Healthy

Keywords

CYP2C8genetic polymorphismrosiglitazoneKorean

Outcome Measures

Primary Outcomes (1)

  • AUC

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

    12hr

Secondary Outcomes (1)

  • Cmax

    12hr

Study Arms (2)

rosiglitazone

ACTIVE COMPARATOR

avandia

Drug: RosiglitazoneGenetic: CYP2C8 genotype

genetic polymorphism

ACTIVE COMPARATOR

avandia CYP2C8 genotype

Drug: RosiglitazoneGenetic: CYP2C8 genotype

Interventions

RosiglitazoneDRUG

single oral administration of 4mg of rosiglitazone

Also known as: Avandia
genetic polymorphismrosiglitazone
CYP2C8 genotypeGENETIC

CYP2C8\*11.

Also known as: avandia
genetic polymorphismrosiglitazone

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer

You may not qualify if:

  • Medical problems in taking probe drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rosiglitazone

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jae-Gook Shin, MD, PhD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pharmacology and Pharmacogenomics Research Center

Study Record Dates

First Submitted

December 6, 2011

First Posted

June 7, 2013

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

June 7, 2013

Record last verified: 2013-06