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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
56
Each tablet contains 100 mg of Eltrombopag (Dose 200 mg)
Each capsule contains 200 mg of Boceprevir (Dose 800 mg)
Each tablet contains 375 mg of Telaprevir (Dose 750 mg)
GSK Investigational Site
Baltimore, Maryland, United States
Composite pharmacokinetic (PK) parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: area under the concentration time-curves from time zero to infinity AUC(0-infinity) and maximum concentration (Cmax).
Time frame: For 17 days
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma boceprevir PK Parameters: AUC from time zero to the dosing interval AUC(0-τ), Cmax, and Concentraction at end of the dosing interval (Cτ)
Time frame: For 17 days
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC(0-infinity) and Cmax
Time frame: For 17 days
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma telaprevir PK Parameters: AUC(0-τ), Cmax, and Cτ.
Time frame: For 17 days
Composite PK parameters of eltrombopag following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC from time zero to the last measurable concentration (AUC(0-t)), AUC obtained by extrapolation (%) (%AUCex), time from administration to first quantifiable concentration (tlag), time from administration to Cmax (tmax), elimination half life (t1/2), and apparent clearance (CL/F).
Time frame: For 17 days
Composite PK parameters of boceprevir following administration of boceprevir for 10 days with a single dose of eltrombopag
Plasma boceprevir PK Parameter: tmax.
Time frame: For 17 days
Composite PK parameters of eltrombopag following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma eltrombopag PK Parameters: AUC(0-t), %AUCex, tlag, tmax, t1/2, and CL/F.
Time frame: For 17 days
Composite PK parameters of telaprevir following administration of telaprevir for 10 days with a single dose of eltrombopag
Plasma telaprevir PK Parameter: tmax.
Time frame: For 17 days
Safety and tolerability as assessed by the collection of adverse events
Time frame: For 28 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests.
Time frame: For 28 days
Safety and tolerability as assessed by change from baseline in vital sign
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Time frame: For 28 days
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