A Drug Interaction Study Between Simvastatin and GSK376501
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|ClinicalTrials.gov Identifier: NCT00605449|
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : October 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: GSK376501||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Randomized, Open-Label, 3 Period Crossover Drug Interaction Study Between Simvastatin and GSK376501 in Healthy Subjects|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
- drug plasma levels of GSK376501: [ Time Frame: Day 7 Periods 1, 2 & 3 ]
- drug plasma levels of GSK376501: [ Time Frame: Day 7 all periods ]
- adverse events, vital signs, con meds: [ Time Frame: each visit, all periods ]
- labs: [ Time Frame: Days 4 & 8 all periods ]
- ECGs: [ Time Frame: Days 1-7 all periods ]
- Simvastatin acid Day 7 tmax and t1/2.
- Simvastatin Day 7 AUC(0-24), Cmax, tmax and t1/2.
- GSK376501 Day 7 AUC(0-24), Cmax, tmax and t1/2.
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): NCT00605449
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials, MD, MPH||GlaxoSmithKline|