NCT06740825

Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects

A Phase 1, Open Label, Randomized, Parallel Drug Interaction Study to Evaluate the Effect of a CYP3A Weak Inducer Rufinamide on the Pharmacokinetics of Quizartinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Quizartinib	Single oral dose of 60 mg
DRUG	Rufinamide	Twice daily (BID) dose of 400 mg on Days 1 through 32

Timeline

• Start date: 2024-10-29
• Primary completion: 2024-12-09
• Completion: 2024-12-09
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study