Low Platelet Count thrombocytopenia
Conditions
Interventions
The study will consist of 4 periods. In total the subject will receive one
single dose of 25 mg and 75 mg eltrombopag as an oral capsule, and 25 mg and 75
mg eltrombopag as an oral tablet (1 single
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male and female subjects who are 18 to 55 years of age on the day of Informed Consent signature - Subjects in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, and ECG, as well as laboratory values within the reference range at the local laboratory, unless deemed not clinically significant by the Investigator or designee - Body mass index (BMI) of 18.0 to 29.9 kg/m2, with body weight greater than or equal to 50 kg for males and 45 kg for females and no more than 120 kg
Exclusion criteria
Exclusion criteria: - A history or presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome - Presence of hepatitis B or C virus, or human immunodeficiency virus - Clinical evidence of renal disease or liver disease or liver injury - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs, such as gastrectomy, gastroenterosomy, bowel restriction or colecystectomy - Administration of CYP3A4/5 inhibitors or inducers within 4 weeks prior to screening and until 2 weeks after EOT, for their potential interaction with hormonal contraceptive methods - Consumption of any antacids, e.g., liquid antacids (e.g., Maalox, Mylanta, Amphogel, Milk of Magnesia), chewable antacids (e.g., TUMS*) during 14 days prior the first dose of study medication and until end-of-treatment -Not willing to avoid the following fruits and their juices: grapefruit, grapefruit hybrids, Seville oranges, pomelos, pomegranates, cranberries and star fruits from 14 days prior to the first dosing and until the end-of-treatment - Use of any prescription or non-prescription medication (OTC) (including aspirin and non-steroidal anti-inflammatory drugs [NSAIDs]), herbal medication, dietary supplements or vitamins during 14 days prior to first dosing and until end-of-treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - AUClast, AUCinf, Cmax Tmax, Tlag, T1/2, CL/F, Vz/F | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) and severe adverse events (SAEs), changes in vital signs, changes in electrocardiograms (ECGs), changes in laboratory results (hematology, blood chemistry, and coagulation panel). | — |
Countries
Netherlands
Outcome results
None listed