BridgeMD
Comparative Bioavailability of Lenvatinib 10 mg Capsules in Healthy Subjects
EU CTIS ID: 2022-501327-25-00
What this study is testing
To compare the bioavailability of Test-1 and Test-2 products versus Reference product under fasting and fed conditions.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to first study period until at least 4 weeks after the last study drug administration.
- A male subject who is sexually active with a female partner of childbearing potential (pregnant or non-pregnant) must use contraception (condom) from admission to first study period until at least 4 weeks after the last study drug administration.
- A male subject must be willing not to donate sperm from admission to first study period until 4 weeks following the last study drug administration.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
You likely can't join if
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- History of thyroid dysfunction.
- Family history of sudden death before 40 years old, short or long QT syndrome.
- Systolic Blood Pressure (SBP) >140mmHg and/or Diastolic Blood Pressure (DBP) >90 mmHg.
- Heart rate <50 bpm in ECG.
- Baseline QTcF interval >450 msec if man or >470 msec if woman, or <350 msec.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to first study period until at least 4 weeks after the last study drug administration.
- A male subject who is sexually active with a female partner of childbearing potential (pregnant or non-pregnant) must use contraception (condom) from admission to first study period until at least 4 weeks after the last study drug administration.
- A male subject must be willing not to donate sperm from admission to first study period until 4 weeks following the last study drug administration.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
What rules you out
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients.
- History of thyroid dysfunction.
- Family history of sudden death before 40 years old, short or long QT syndrome.
- Systolic Blood Pressure (SBP) >140mmHg and/or Diastolic Blood Pressure (DBP) >90 mmHg.
- Heart rate <50 bpm in ECG.
- Baseline QTcF interval >450 msec if man or >470 msec if woman, or <350 msec.
- Serum transaminases ALT or AST above the upper limit of the normal range.
- Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Serum calcium, potassium or magnesium below the lower limit of the normal range.
- Presence of clinically relevant proteinuria.
- Positive result in drugs-of-abuse or ethanol tests.
- Known severe hypersensitivity reaction to any other drug.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman, positive pregnancy test in serum.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or non-prescription medicinal products, vitamins, food supplements or herbal supplements (including St John’s Wort) within the previous 2 weeks, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous 14 days.
- Clinically significant abnormalities on 12-lead ECG.
- Positive result in drugs-of-abuse or ethanol tests.
- If woman, positive pregnancy test in urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
- History of fistula or gastrointestinal perforation.
- History of significant hemorrhagic event.
- History of cardiovascular events, such as myocardial infarction, angina pectoris, congestive heart failure, or cerebrovascular accident.
- History of short QT syndrome or long QT syndrome.
- History of clinically significant arrythmias (e.g. documented supraventricular or ventricular tachyarrhythmias, second or third degree atrioventricular block).
- History of or risk for venous and/or arterial thromboembolic events.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.