Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.

Summary

This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of eltrombopag on Day 1, and PK sampling will occur for 72 hours. In Period 2, subjects will receive LPV/RTV for 14 days with PK sampling for 12 hours. In Period 3, subjects will receive a single dose of eltrombopag with LPV/RTV on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs.

Timeline

Start

2009-01-19

Primary completion

2009-03-11

Completion

2009-03-11

Publications

• Background Wire MB, McLean HB, Pendry C, Theodore D, Park JW, Peng B. Assessment of the pharmacokinetic interaction between eltrombopag and lopinavir-ritonavir in healthy adult subjects. Antimicrob Agents Chemother. 2012 Jun;56(6):2846-51. doi: 10.1128/AAC.05214-11. Epub 2012 Mar 5.

Drugs

Indications