A Pharmacokinetic Study of Eltrombopag 50 Milligram (mg) in Healthy Volunteers Under Fasting Conditions

Who may be able to join

• Subjects' participation must be voluntary according to the General Health Law and an informed consent form must be obtained for each subject before their participation. Compliance to Helsinki´s Declaration, its Japan Review and good clinical practice (GCP) should be followed.
• Mexican male and female healthy volunteers with 18 to 50 years old will be included. A female subject is eligible to participate if she is of, Non-childbearing potential defined as pre menopausal females with a documented tubal ligation or hysterectomy (for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] > 40 milliinternational units per milliliter (MlU/ml) and estradiol < 40 picogram per milliliter [pg/ml] [<147 picomole per liter (pmol/L)] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods as described by the Investigator/designee, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method). Child-bearing potential with negative pregnancy test as determined by (serum or urine) human chorionic gonadotropin (hCG) test at screening or prior to dosing abbr de ante meridiem (AN ). Agrees to use one of the contraception methods listed by Investigator/designee for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until seven days after the drug administration. or has only same-sex partners, when this is her preferred and usual lifestyle.
• Body mass index (BMI) between 18-27.0 kilogram per meter (kg/m^2) according to Quetelet.
• Volunteers should be healthy as determined by their medical evaluation done by the physicians in the center and by their safety labs results done at a certified local laboratory.
• Variation limits within normal ranges on their screening visit are: Blood pressure (BP) (seating) between 90 and 130 millimeters of mercury (mm Hg) for Systolic pressure and between 60 and 90 mmHg diastolic pressure, heart rate (HR) between 55 and 100 beats per minute (bpm) and respiratory rate (RR) between 14 and 20 per minute.
• Safety laboratory tests to be done include: Hematology: Complete blood count with differential, Hemoglobin, Hematocrit, platelet count, etc; Blood chemistry: Albumin, Alkaline phosphatase, aspartate-aminotransferase (AST), alanine aminotransferase (ALT), Urea, Calcium, Chloride, Glucose, Phosphate, Potassium, Serum creatinine, Sodium, Total bilirubin, Total protein, etc; Urinalysis: pH, Specific gravity, Protein, Glucose, Ketones, Bilirubin, Occult blood and cells, Nitrite, Urobilinogen, Leukocytes, Microscopic examination; Hepatitis B and C tests; human Immunodeficiency Virus (HIV) test; Serum pregnancy test; Drug abuse test; Alcohol detection test; Urine Pregnancy test; ECG; Chest X ray. Normal variation limits for laboratory values will be +/- 10% from normal range, unless the principal investigator (PI) considers another deviation as clinically non-significant. In that case, values should be documented in the volunteer's clinical file as well as the decision to include the subject prior consult with GlaxoSmithKline (GSK) Medical Monitor. For safety reasons and as per the PI criteria additional ECG or safety labs may be performed.