A Phase 1 interventional study of Eltrombopag and Cyclosporine in Purpura, Thrombocytopenic, Idiopathic, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Other
A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to support the use of these drugs together in subjects, such as those with severe aplastic anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I, open-label, randomized, three-period cross-over study in healthy adult subjects. The study consists of a screening visit and three treatment periods. All subjects will be randomized to receive one of the three treatments in each treatment period separated by washout periods of 3-10 days. The total duration of a subject's participation in the study from screening to final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at least 10 subjects per sequence (total 30).
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 39 is below the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used.
Participants will receive treatment D0 in treatment period 1, D1 in treatment period 2 and D2 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 milligram (mg), D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days
Drug: Eltrombopag · Drug: Cyclosporine
Participants will receive treatment D1 in treatment period 1, D0 in treatment period 2 and D2 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 mg, D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days
Drug: Eltrombopag · Drug: Cyclosporine
Participants will receive treatment D1 in treatment period 1, D2 in treatment period 2 and D0 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 mg, D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days
Drug: Eltrombopag · Drug: Cyclosporine
White to off white bi-convex round tablets containing eltrombopag 50 mg for oral administration
Soft gelatine capsule containing cyclosporine 100 mg for oral administration. Cyclosporine will be administered at the doses of 200 mg (2 x 100 mg capsules) or 600 mg (6 x 100 mg capsules)
Plasma eltrombopag area under time-concentration curve from time zero to infinity (AUC[0-inf])
Time frame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose in each treatment period
Plasma eltrombopag maximum observed concentration (Cmax)
Time frame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose in each treatment period
Composite of plasma eltrombopag pharmacokinetic (PK) parameters
PK parameters include: area under time-concentration curve from time zero to the time of last quantifiable concentration (AUC\[0-t\]), the percentage of AUC(0-inf) obtained by extrapolation (%AUCex), time to occurrence of Cmax (tmax), terminal phase half-life (t1/2), and apparent oral clearance (CL/F)
Time frame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose in each treatment period
Vital signs assessment
Vital signs will include temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate
Time frame: Up to 6 weeks
Composite clinical laboratory assessments including hematology, clinical chemistry and urinalysis parameters
Time frame: Up to 6 weeks
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: From the start of study treatment until the end of treatment period 3 (assessed up to 18 days)
Electrocardiogram (ECG) assessment
Single 12-lead ECG will be obtained following eltrombopag dosing using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval (QTc)
Time frame: Up to 6 weeks
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline