Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT01955304
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2013-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
Official Title:
A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Fruquintinib (HMPL-013) in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 4mg fruquintinib in normal healthy subjects.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: