drugset / Trial / NCT01411111

A Repeat Dose Study to Investigate the Interaction of GSK2190915 on the Pharmacokinetics of Rosuvastatin

NCT01411111

Phase 1 Completed 28 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils, monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli. GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes, through the blockage of the first committed step in the leukotriene pathway, 5 lipoxygenase (5-LO) activation. GSK2190915 has been shown to be an in vitro inhibitor of human organic anion transporting polypeptides 1B1 and 1B3 (OATP1B1 and OATP1B3), hence there is a potential for a pharmacokinetic drug-drug interaction with OATP1/ B1 substrates such as the anti-lipidemic rosuvastatin. This study will evaluate the effect of repeat oral dosing of GSK2190915 (30milligram (mg) and 100mg) on the steady-state pharmacokinetics (PK) of rosuvastatin (10 mg). In addition, the study will evaluate the safety and tolerability of this combination when co-administered to healthy, adult volunteers in two cohorts.

Timeline

Start
2011-01-06
Primary completion
2011-02-23
Completion
2011-02-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator FIBOFLAPON Small molecule 30 mg Oral
Comparator FIBOFLAPON Small molecule 100 mg Oral
Comparator Rosuvastatin Small molecule 10 mg Oral

Indications