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 impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.
This is a QT assessment study of quizartinib when given as a single oral dose of 90 mg in 70 healthy subjects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Experimental | All participants will receive either an oral dose of 90 mg of quizartinib or placebo on Day 1. On Day 2, all participants will receive the treatment that was not given on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quizartinib | Drug | Participants will receive a single oral dose of 90 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate | Day 1 and Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | TEAEs are defined as new AEs that occur after the first dose of study drug, including 14 days after last dose of study drug" to end of the sentence | From Day 1 up to the last day of Safety Follow-up (approximately 16 days) |
| Pharmacokinetic Parameter: Cmax |
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-blinded study where only the participants will be blinded to the treatment being administered.
Not provided
| Placebo | Other | Participants will receive a single oral dose of 90 mg |
|
Maximum concentration, determined directly from individual concentration-time data |
| Days 1, 2 and 3 |
| Pharmacokinetic Parameter: Tmax | Time of the maximum concentration | Days 1, 2 and 3 |
| Pharmacokinetic Parameter: AUClast | Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration; calculated using the linear up log down | Days 1, 2 and 3 |