A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK1292263 on the pharmacokinetics of rosuvastatin and simvastatin in healthy adult subjects. Each subject will receive single doses of simvastatin and rosuvastatin on two occasions, once alone and once following administration of repeated (BID) doses of GSK1292263.
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects|
- AUC(0-inf) and Cmax of rosuvastatin alone and in the presence of GSK1292263 [ Time Frame: Day 3 and Day 12 ] [ Designated as safety issue: No ]
- AUC(0-inf) and Cmax of simvastatin/simvastatin acid alone and in the presence of GSK1292263 [ Time Frame: Day 1 and Day 10 ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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.Drug: Rosuvastatin
Rosuvastatin 10mg (single dose) on Days 3 and 12.Drug: GSK1292263
GSK1292263 300mg BID Days 6 to 14.