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New treatment option for Hepatic Impairment
Official title Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT06740799
What this study is testing
What is Quizartinib?
Quizartinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatic impairment.
Also referred to as Test Product, VANFLYTA®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- Male and female people 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight...
- In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure®...
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment)...
- In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
See the full eligibility criteria
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- Male and female people 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight of 40 kg at Screening.
- In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram [documentation to confirm tubal occlusion 12...
- Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance...
- In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.
- people with primary biliary cirrhosis or primary sclerosing cholangitis.
- people with history of Gilbert's syndrome.
- Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy).
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- St. Petersburg, Florida, United States
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 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; St. Petersburg, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.