A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects
Summary
The purpose of this study is to test the effects of study drug (GSK1605786) on the blood levels of multiple commonly used drugs that are given to measure how your liver breaks down the study drug. These commonly-used drugs are midazolam, pioglitazone, omeprazole, and rosuvastatin which will determine the effect of GSK1605786 on how the body breaks down (metabolizes) these commonly-used drugs. Blood samples for pharmacokinetic analysis of GSK1605786, and two metabolites, \[GSK2635622 (CCX062) and GSK2656694 (CCX304)\] and four probe substrates will be collected over a 24-hour period after administration. Safety will be assessed by the measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory tests.
Timeline
- Start
- 2011-09-19
- Primary completion
- 2011-11-10
- Completion
- 2011-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 3 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 40 mg | Oral |
| Subject | Pioglitazone | Small molecule | 15 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | vercirnon | Small molecule | 500 mg | Oral |