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This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit. During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
This is a randomized, open-label, five-period, balanced crossover study conducted in approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects receive five eltrombopag treatments: tablet fasted, PfOS fasted, PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day washout between periods, and between the last dose of study drug and the follow-up visit. During each treatment period, subjects undergo serial PK sampling over 72 hours for measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical safety laboratory assessments, and adverse events reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B | Experimental | 25 mg powder for oral suspension single dose fasted. |
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| Arm C | Experimental | 25 mg powder for oral suspension administered with a meal |
|
| Arm D | Experimental | 25 mg powder for oral suspension administered 2 hours prior to meal |
|
| Arm E | Experimental | 25 mg powder for oral suspension administered 2 hours after to meal |
|
| Arm A | Other | Commercially available eltrombopag 25 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | 25 mg tablet |
| |
| Eltrombopag |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the relative bioavailability of a PfOS formulation relative to the commercial eltrombopag 25 mg tablet formulation in healthy adult subjects. | 72 hours x 2 periods | |
| Evaluate the effect of a high calcium, moderate fat and calorie meal on the pharmacokinetics of a single oral 25 mg dose of eltrombopag PfOS in healthy adult subjects when eltrombopag is administered concurrently, two hours before, or two hours afte | 72 hours x 3 periods |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of single oral doses of eltrombopag. | 12-14 weeks |
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Inclusion Criteria:
Healthy subjects with no clinically significant abnormality identified by physician by evaluation of medical history, physical examination, clinical laboratory tests or electrocardiogram (ECG).
Male and female subjects between the ages of 18 to 64 years of age inclusive, at the time of signing the informed consent.
Subject is able to understand and comply with the protocol requirements, instructions and restrictions.
Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the consent form.
Body weight ≥ 50kg (110 lbs) for men and ≥ 45 kg (99 lbs) for women and body mass index (BMI) of 18.5 to 29.9 kg/m2 inclusive.
A platelet count within normal range and not > 400,000 plt/uL.
Male subjects, who are not surgically sterile, must agree on abstinence or to use a double barrier method, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository). This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of medication.
A female subject is eligible to participate if she is neither pregnant nor lactating, and falls into one of the following categories:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22336488 | Background | Wire MB, Bruce J, Gauvin J, Pendry CJ, McGuire S, Qian Y, Brainsky A. A randomized, open-label, 5-period, balanced crossover study to evaluate the relative bioavailability of eltrombopag powder for oral suspension (PfOS) and tablet formulations and the effect of a high-calcium meal on eltrombopag pharmacokinetics when administered with or 2 hours before or after PfOS. Clin Ther. 2012 Mar;34(3):699-709. doi: 10.1016/j.clinthera.2012.01.011. Epub 2012 Feb 14. |
| Label | URL |
|---|---|
| Results for study 111718 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D011693 | Purpura |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Drug |
25 mg powder for oral suspension |
|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |