A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
|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 ]
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|