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Tyrosine Kinase Inhibitor

Fruquintinib for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Hutchmed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 11
Awards & highlights

Study Summary

This trial is testing how well the body processes a new drug, fruquintinib, when the liver is not functioning properly.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC 0-inf
AUC 0-t
Maximum Plasma Concentration [Cmax]
Secondary outcome measures
Incidence of Adverse Events/Serious Adverse Events

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3 (mild hepatic impairment)Experimental Treatment1 Intervention
8 subjects with mild hepatic impairment will receive a single dose of 5 mg (1 x 5 mg) fruquintinib
Group II: Cohort 2 (moderate hepatic impairment)Experimental Treatment1 Intervention
8 subjects with moderate hepatic impairment will receive a single dose of 2 mg (2 x 1 mg) fruquintinib
Group III: Cohort 1 (healthy subjects)Experimental Treatment1 Intervention
8 healthy subjects with normal hepatic function will receive a single dose of 5 mg (1x5 mg) fruquintinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fruquintinib
2021
Completed Phase 3
~1680

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

HutchmedLead Sponsor
27 Previous Clinical Trials
5,330 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
13,533 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fruquintinib Hepatic Impairment Study
2022. "Fruquintinib Hepatic Impairment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216367.
~5 spots leftby Apr 2025
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