drugset / Trial / NCT01873339

Pharmacokinetic Interaction of Darapladib and CYP 3A4 in Healthy Subjects

NCT01873339

Phase 1 Completed 26 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

This study will determine the effect of single and repeat administration of darapladib, a novel, selective, orally active inhibitor of lipoprotein associated phospholipase A2 (Lp-PLA2) currently under clinical development on the pharmacokinetics of a single oral dose of midazolam, a cytochrome P450 3A4 (CYP3A4) probe substrate. This study will investigate the inductive and inhibitory effect of darapladib on CYP3A4 metabolic pathway.

Timeline

Start
2013-06-19
Primary completion
2013-09-12
Completion
2013-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Darapladib Small molecule 160 mg Oral
Subject Midazolam Small molecule 5 mg Oral

Indications