NCT06740799 Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
| NCT ID | NCT06740799 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daiichi Sankyo |
| Condition | Hepatic Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-09-30 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
Eligibility Criteria
Key Inclusion Criteria: 1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. 2. Male and female subjects 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. 3. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from Screening until 7 months after the dose of quizartinib 4. In females, agreement to not retrieve eggs/ova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later. 5\. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib Key Exclusion: 1. 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 to the study procedures, or the validity of the study results. 2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib. 3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis. 4. Subjects with history of Gilbert's syndrome. 5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib. 6. 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).
Contact & Investigator
Global Clinical Leader
STUDY DIRECTOR
Daiichi Sankyo
Frequently Asked Questions
Who can join the NCT06740799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatic Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06740799 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06740799 currently recruiting?
Yes, NCT06740799 is actively recruiting participants. Contact the research team at CTRinfo_us@daiichisankyo.com for enrollment information.
Where is the NCT06740799 trial being conducted?
This trial is being conducted at Miami, United States, Miami, United States, St. Petersburg, United States.
Who is sponsoring the NCT06740799 clinical trial?
NCT06740799 is sponsored by Daiichi Sankyo. The principal investigator is Global Clinical Leader at Daiichi Sankyo. The trial plans to enroll 12 participants.