A Phase 1 interventional study of Quizartinib and Rufinamide in Healthy Subjects, sponsored by Daiichi Sankyo. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Treatment
This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects
This is a clinical pharmacology study with 2 treatment groups (Test treatment group receiving both rufinamide weak CYP3A inducer and quizartinib and Reference treatment group receiving quizartinib only) investigating the effect of rufinamide on the PK of quizartinib in healthy subjects.
Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
On Day 1 through Day 32, participants will receive an oral dose of 400-mg of rufinamide twice daily (BID). In addition, on Day 12, subjects will receive an oral single dose of 60-mg quizartinib
Drug: Quizartinib · Drug: Rufinamide
On Day 1, participants will receive an oral dose of 60-mg quizartinib
Drug: Quizartinib
Single oral dose of 60 mg
Also known as: VANFLYTA®
Twice daily (BID) dose of 400 mg on Days 1 through 32
Pharmacokinetic Parameter: Cmax
Cmax is defined as maximum concentration, determined directly from individual concentration-time data
Time frame: From day of first dose, Day 1, up to Day 33
Pharmacokinetic Parameter: AUClast
AUClast is defined as area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down
Time frame: From day of first dose, Day 1, up to Day 33
Pharmacokinetic Parameter: AUCinf
AUCinf is defined as area under the concentration-time curve from time-zero extrapolated to infinity
Time frame: From day of first dose, Day 1, up to Day 33
Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as new AEs that occur after the first dose of study drug
Time frame: From day of first dose, Day 1 up to the last day of Safety Follow-up, up to approximately 40 days
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo