NCT01657552

Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects

A Phase I, Open-label, Three-Period, Single Sequence, Crossover Study Evaluating the Drug-Drug Interaction Between Eltrombopag and Boceprevir and Between Eltrombopag and Telaprevir in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP 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. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.

Conditions

• Thrombocytopaenia

Interventions

Type	Name	Description
DRUG	Eltrombopag	Each tablet contains 100 mg of Eltrombopag (Dose 200 mg)
DRUG	Boceprevir	Each capsule contains 200 mg of Boceprevir (Dose 800 mg)
DRUG	Telaprevir	Each tablet contains 375 mg of Telaprevir (Dose 750 mg)

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-26
• Completion: 2012-10-26
• First posted: 2012-08-06
• Last updated: 2017-11-13

Locations

1 site across 1 country: United States