A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01101568|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Simvastatin Drug: Rosuvastatin Drug: GSK1292263||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects|
|Actual Study Start Date :||April 14, 2010|
|Actual Primary Completion Date :||June 24, 2010|
|Actual Study Completion Date :||June 24, 2010|
Experimental: Single Sequence
Simvastatin will be administered on Day 1 and Day 10. Rosuvastatin will be administered on Day 3 and Day 12. GSK1292263 will be administered on Days 6 to 14.
Simvastatin 40mg (single dose) on Days 1 and 10.
Rosuvastatin 10mg (single dose) on Days 3 and 12.
GSK1292263 300mg BID Days 6 to 14.
- AUC(0-inf) and Cmax of rosuvastatin alone and in the presence of GSK1292263 [ Time Frame: Day 3 and Day 12 ]
- AUC(0-inf) and Cmax of simvastatin/simvastatin acid alone and in the presence of GSK1292263 [ Time Frame: Day 1 and Day 10 ]
- Safety and tolerability: adverse events, cardiovascular findings (blood pressure, heart rate, ECGs) and clinical laboratory values. [ Time Frame: Throughout the study (Day 1 to Day 25) ]
- PK parameters: time to maximum plasma concentration, apparent plasma terminal elimination half-life and area under the plasma concentration-time curve for rosuvastatin [AUC(0-72 hours)] and simvastatin/simvastatin acid [AUC(0-24h)] [ Time Frame: 15 days ]
- PK parameter values: AUC(0-24h), Cmax, tmax and t1/2 for GSK1292263 and assessment of steady-state [ Time Frame: From Day 6 to Day 15 ]
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): NCT01101568
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|