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This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 4mg fruquintinib in normal healthy subjects.
This study will be an open-label, randomized, two-period, crossover PK food effect study of fruquintinib administered orally at 4mg. Subjects will be screened for eligibility up to 14 days prior to entry into the study.
For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 4 mg fruquintinib in either the fasted or fed state. Subjects will remain at the CRU for at least 120 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring. Subjects will return to the CRU for safety assessment for up to 336 hours postdose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-fasted dosing followed by fed dosing | Experimental | Experimental: Fasted dosing of fruquintinib followed by fed dosing; Dosing in the fasted state followed by fed dosing |
|
| B-fed dosing followed by fasted dosing | Experimental | Experimental: Fed dosing of fruquintinib followed by fasted dosing; Dosing in the fed state followed by fasted dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fruquintinib | Drug | Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| • To determine the effect of food on the PK of a single dose of 4mg fruquintinib in normal healthy subjects. | Blood samples for PK analysis of serum fruquintinib levels will be collected for a 2-week period following each of 2 doses. | Planned Enrollment/Screening Duration: Approximately 2 weeks. Length of Each Confinement: Approximately 7days prior to dose until approximately 120 hours postdose. Planned Study Conduct Duration: Approximately 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • To assess the safety and tolerability of single doses of 4mg fruquintinib | Safety will be assessed by physical exam, clinical laboratory evaluations and ECGs. | Planned Enrollment/Screening Duration: Approximately 2 weeks. Length of Each Confinement: Approximately 7days prior to dose until approximately 120 hours postdose. Planned Study Conduct Duration: Approximately 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31272709 | Derived | Qian H, Fan S, Li K, Sai Y, Su W, Chen Q, Liu Y, Li T, Wang W, Jia J, Yu C, Liu Y. Effects of a High-fat Meal on the Pharmacokinetics of the VEGFR Inhibitor Fruquintinib: A Randomized Phase I Study in Healthy Subjects. Clin Ther. 2019 Aug;41(8):1537-1544. doi: 10.1016/j.clinthera.2019.05.014. Epub 2019 Jul 1. |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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