A study to compare the absorption of eltrombopag olamine in healthy volunteers to ensure the tablets work the same way for patients with thrombocytopenia or aplastic anemia.

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What is this study about?

This study focuses on Thrombocytopenia, a condition where there is a low number of platelets in the blood, and Aplastic anemia, a serious condition where the body stops producing enough new blood cells. The research aims to demonstrate the bioequivalence, or how similarly the body absorbs and uses a medicine, between two different versions of the drug eltrombopag.

Participants will receive eltrombopag in the form of a 75 mg film-coated tablet, which is a pill covered in a thin layer to make it easier to swallow. The study is conducted under fasting conditions, meaning no food is consumed for a certain period before taking the medication. The process involves a crossover design, where individuals receive both the test version and the comparator version of the medication at different times during the study period.

Who Can Join the Study?

You must provide your free written informed consent, which means you sign a document agreeing to participate after being fully informed about the study.
You must be willing to follow all the rules and steps required by the study.
For women, you must either not be able to have children or, if you are able to have children, you must agree to use a reliable contraceptive method (a way to prevent pregnancy) starting 4 weeks before the first dose and continuing for at least 1 week after the last dose.
You must have a negative test for SARS-CoV-2 (the virus that causes COVID-19) or have a valid digital certificate showing you have recovered from it.
You must be between 18 and 55 years old at the time you sign the consent form.
Your body mass index (BMI), which is a measure of your body weight relative to your height, must be between 18.0 and 31.0.
You must not have any important medical illnesses in your history.
You must not have any unusual findings during a physical examination (a doctor’s check-up of your body).
Your 12-lead ECG, which is a test that records the electrical activity of your heart, must show no unusual patterns.
Your clinical laboratory tests, such as blood or urine tests, must show no significant abnormalities.
You must test negative for HIV (a virus that affects the immune system), Hepatitis B, and Hepatitis C (viruses that affect the liver).
You must be a non-smoker or someone who has not used any tobacco or nicotine products for at least 3 months.

Who Cannot Join the Study?

People of Eastern or Southeastern Asian descent (such as Chinese, Japanese, Taiwanese, or Korean).
A history of cataracts, which is a clouding of the lens in the eye that affects vision.
Platelet levels (cells in the blood that help with clotting) that are too low or too high (above 400 x 10⁹/L).
Levels of ALT or AST, which are enzymes (proteins that help chemical reactions) in the blood that indicate liver health, being outside the normal range.
A creatinine clearance (a measure of how well the kidneys filter waste) of less than 90 mL/min.
Total bilirubin (a yellowish substance produced by the liver) levels that are above the upper limit of normal.
A resting heart rate (the number of times your heart beats per minute) of less than 50 beats per minute during an ECG (a test that records the electrical activity of the heart).
A QTcF interval (a specific measurement of the heart’s electrical timing) longer than 450 milliseconds for men or 470 milliseconds for women.
Positive tests for drugs of abuse, ethanol (alcohol), or cotinine (a substance found in the body after using nicotine).
The use of a depot injection (a long-acting medication injected into muscle) or a drug implant within the last 6 months.
Drinking more than 14 units of alcohol per week for men or more than 7 units for women over the last 6 months.
A known hypersensitivity or allergy to the study drug or any of its excipients (inactive ingredients used to make the medicine).
Daily consumption of more than 500 mg of methylxanthines, which are substances found in coffee, tea, cola, sodas, and chocolate.
Participating in any other clinical trial within the last 2 months.
Participating in more than 2 clinical trials within the last 12 months.
Donating blood, losing a large amount of blood (450 mL or more), or having plasmapheresis (a process that removes plasma from the blood) within the last 2 months.
Difficulty with fasting (not eating for a period of time) or having dietary restrictions (such as being vegan or lactose intolerant) that interfere with the study diet.
Veins in either arm that are not suitable for intravenous puncture (inserting a needle into a vein).
Difficulty swallowing capsules or tablets.
Women who have a positive pregnancy test in their blood or urine.
Women who are currently breast-feeding.
Any recent illness, condition, or treatment that the doctor believes makes participation unsafe or could interfere with pharmacokinetics (how the body processes the drug, including how it is absorbed and cleared).
The use of any prescription or non-prescription medicines, including vitamins, supplements, or herbal products, within the last 2 weeks, unless approved by the doctor.
Eating products from pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit within the last week.
Any medical condition affecting the gastrointestinal (stomach and intestines), renal (kidneys), or hepatic (liver) systems, such as peptic ulcers, inflammatory bowel disease, or pancreatitis (inflammation of the pancreas).
History of cholecystectomy (surgical removal of the gallbladder) or gastrectomy (surgical removal of part or all of the stomach).
A history of splenectomy (surgical removal of the spleen).
A history of liver impairment (reduced liver function).
A history of thromboembolic events (blood clots that travel through the bloodstream) or hypercoagulable disorders (conditions that make the blood clot too easily).
A history of platelet disorders (conditions affecting blood clotting cells).
Any other condition that the investigator determines makes a person unsuitable for the study.

Where you can join this trial?

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Site Name	City	Country	Status
Bsqseomxvfss Ipicrlhqzoii E Dmshptwdcpecfno Em Sepls Lwfx	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	10.02.2023

Trial locations

Eltrombopag is a medication taken by mouth that is being tested to see how well it works in the body compared to another version of the same medicine.

Eltrombopag is the comparison medicine used in this study to serve as a standard for measuring how the test medication performs.

Investigated diseases:

Thrombocytopenia

Thrombocytopenia – This condition occurs when there is a lower than normal number of platelets in the blood. Platelets are the cells responsible for helping the blood to clot. The condition can progress as the body destroys platelets too quickly or fails to produce enough of them. This imbalance can lead to an increased tendency for bleeding or bruising.

Aplastic anemia – This is a condition where the body stops producing enough new blood cells. It involves a decrease in red blood cells, white blood cells, and platelets. The condition typically progresses as the bone marrow becomes damaged and cannot function properly. As a result, the blood lacks the necessary components to carry oxygen or fight infections effectively.

Trial ID:

2022-502701-15-00

Protocol code:

BLCL-ELT-FDA-01

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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A study to compare the absorption of eltrombopag olamine in healthy volunteers to ensure the tablets work the same way for patients with thrombocytopenia or aplastic anemia.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?