Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 9:19 PM
Study NCT ID:
NCT05216367
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2022-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fruquintinib Hepatic Impairment Study
Sponsor:
Hutchmed
Organization:
Study Overview
Official Title:
An Open-Label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib
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:
An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib
Detailed Description:
This is a multicenter open-label, single-dose, single-period, sequential study in subjects without cancer with the primary objective of determining the effect of moderate and mild hepatic impairment on the PK of fruquintinib. The secondary objective is to evaluate the safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.
Initially, subjects with moderate hepatic impairment will be enrolled. An interim pharmacokinetic (PK) analysis will be performed to evaluate the need to enroll subjects with mild hepatic impairment. Subjects with normal hepatic function will be enrolled after all other subjects have completed the study and will be matched for sex, age and body mass index. Subjects with hepatic impairment will be enrolled based on the hepatic function classification determined by Child-Pugh scoring.
Subjects with moderate hepatic impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib PK exposure. Subjects with mild hepatic impairment or normal hepatic function will receive a single dose of 5 mg fruquintinib.
Initially, subjects with moderate hepatic impairment will be enrolled. An interim pharmacokinetic (PK) analysis will be performed to evaluate the need to enroll subjects with mild hepatic impairment. Subjects with normal hepatic function will be enrolled after all other subjects have completed the study and will be matched for sex, age and body mass index. Subjects with hepatic impairment will be enrolled based on the hepatic function classification determined by Child-Pugh scoring.
Subjects with moderate hepatic impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib PK exposure. Subjects with mild hepatic impairment or normal hepatic function will receive a single dose of 5 mg fruquintinib.
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?: