Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A (Test) | Experimental | 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 |
|
| Treatment Group B (Reference) | Experimental | On Day 1, participants will receive an oral dose of 60-mg quizartinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quizartinib | Drug | Single oral dose of 60 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Cmax | Cmax is defined as maximum concentration, determined directly from individual concentration-time data | 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 | 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 | From day of first dose, Day 1, up to Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | TEAEs are defined as new AEs that occur after the first dose of study drug | From day of first dose, Day 1 up to the last day of Safety Follow-up, up to approximately 40 days |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCT | San Antonio | Texas | 78217 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C544967 | quizartinib |
| C079703 | rufinamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No masking.
Not provided
| Rufinamide | Drug | Twice daily (BID) dose of 400 mg on Days 1 through 32 |
|