Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT05368805
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2022-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fruquintinib DDI Study With P-gp and BCRP Substrates
Sponsor:
Hutchmed
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, 2-part, 2-period Fixed-sequence Study to Evaluate the Effect of Fruquintinib on the Pharmacokinetics of Dabigatran Etexilate (A P-GP Substrate) and Rosuvastatin (A BCRP Substrate) in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-10
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:
Fruquintinib DDI Study with P-gp and BCRP Substrates
Detailed Description:
A phase 1, open-label, 2-part, 2-period fixed-sequence study to evaluate the effect of Fruquintinib on the pharmacokinetics of Dabigatran Etexilate (A P-GP substrate) and Rosuvastatin (A BCRP substrate) in healthy subjects
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?: