Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04510649
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2020-08-10
Brief Title:
Surufatinib DDI With a PPI and a CYP3A Inducer
Sponsor:
Hutchison Medipharma Limited
Organization:
Hutchmed
Study Overview
Official Title:
Ph 1 Open-label 2 Part 2 Period Fixed-Sequence Crossover Study to Assess the Effect of Rabeprazole a Proton Pump Inhibitor and the Effect of Rifampin a Strong CYP3A Inducer on the Pharmacokinetics of Surufatinib in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2020-08
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:
The purpose of this is to evaluate the effect of proton pump inhibitor rabeprazole and the effect of a CYP3A inducer rifampin on the pharmacokinetics of Surufatinib
Detailed Description:
This study will be a single center open-label 2 part 2 period fixed-sequence crossover study to be conducted with 28 healthy male and female subjects part A and part B Subjects will be enrolled in either part A or part B
In Part A subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rabeprazole in treatment Period 2
In Part B subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rifampin in treatment Period 2
PK samples will be collected through out both study periodsSubjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15 part A and Day 16 part B
In Part A subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rabeprazole in treatment Period 2
In Part B subjects will be administered surufatinib alone in treatment Period 1 and co-administered with rifampin in treatment Period 2
PK samples will be collected through out both study periodsSubjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15 part A and Day 16 part B
Study Oversight
Has Oversight DMC:
None
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?:
None