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NCT01657552

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

Completed Phase 1 Last updated 13 November 2017
What this trial tests

Phase 1 trial testing Eltrombopag in Thrombocytopaenia in 56 participants. Completed in 26 October 2012.

Timeline
1 August 2012
Primary endpoint
26 October 2012
26 October 2012

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment56
Start date1 August 2012
Primary completion26 October 2012
Estimated completion26 October 2012
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 64, any sex, with Thrombocytopaenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Erratum for Wire et al., Lack of clinically significant pharmacokinetic interaction between the thrombopoietin receptor agonist eltrombopag and hepatitis C virus protease inhibitors boceprevir and telaprevir.
    Wire MB, Fang L, Hussaini A, Kleha JF, et al · · 2015 · PMID 25862822 · DOI 10.1128/aac.00567-15

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Other trials of Eltrombopag

Trials testing the same drug.

Other recruiting trials for Thrombocytopaenia

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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