Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 12:16 AM
Study NCT ID:
NCT04372394
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
Official Title:
A Phase 1, Two Period Crossover Study to Assess the Effect of a High Fat Meal on the Pharmacokinetics of Surufatinib in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-07
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 be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.
Detailed Description:
This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
* Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
* Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
* Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
* Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: