| Trial ID: | L3558 |
| Source ID: | NCT01101568
|
| Associated Drug: |
Simvastatin
|
| Title: |
A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Simvastatin|DRUG: Rosuvastatin|DRUG: GSK1292263
|
| Outcome Measures: |
Primary: AUC(0-inf) and Cmax of rosuvastatin alone and in the presence of GSK1292263, Day 3 and Day 12|AUC(0-inf) and Cmax of simvastatin/simvastatin acid alone and in the presence of GSK1292263, Day 1 and Day 10 | Secondary: Safety and tolerability: adverse events, cardiovascular findings (blood pressure, heart rate, ECGs) and clinical laboratory values., 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)], 15 days|PK parameter values: AUC(0-24h), Cmax, tmax and t1/2 for GSK1292263 and assessment of steady-state, From Day 6 to Day 15
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
28
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2010-04-14
|
| Completion Date: |
2010-06-24
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-14
|
| Locations: |
GSK Investigational Site, Austin, Texas, 78744, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01101568
|
