Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
← catalyst calendarNCT06740799 · readout in 73 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
12estimated
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-30 | actual | When the study began enrolling |
| Primary completion | 2026-10-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hepatic Impairment
Intervention
- Drug: Quizartinib — also filed as Test Product, VANFLYTA®
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetic Parameter: Cmax
measured From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: Tmax
measured From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: AUClast
measured From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: AUCinf
measured From day of first dose, Day 1, through Day 29
Pharmacokinetic Parameter: t1/2
measured From day of first dose, Day 1, through Day 29
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