Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
NCT06740825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-12-18
Summary
This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects
Conditions
- Healthy Subjects
Interventions
- DRUG
-
Quizartinib
Single oral dose of 60 mg
- DRUG
-
Rufinamide
Twice daily (BID) dose of 400 mg on Days 1 through 32
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Global Clinical Leader · Daiichi Sankyo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-29
- Primary Completion
- 2024-12-09
- Completion
- 2024-12-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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