drugset / Trial / NCT01852565

Study to Determine the Effect of Repeated Administration of Diltiazem on the Pharmacokinetics of Darapladib (Sb-480848).

NCT01852565

Phase 1 Completed 36 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

Darapladib (SB-480848) is a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development by GlaxoSmithKline as a potential anti-atherosclerosis agent for reduction of major adverse cardiovascular (CV) events in patient populations with chronic coronary heart disease and after an acute coronary syndrome. This study will determine the effect of repeated administration of diltiazem on the pharmacokinetics of a repeated administration of darapladib. A drug interaction study with a moderate CYP3A4 inhibitor is warranted to provide guidance to prescribing physicians.

Timeline

Start
2013-05-14
Primary completion
2013-09-30
Completion
2013-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Darapladib Small molecule 160 mg Oral
Subject Diltiazem Small molecule 240 mg Oral

Indications