NCT05216367 is a Phase 1 clinical trial of Fruquintinib in Hepatic Impairment, sponsored by Hutchmed.

Who is sponsoring NCT05216367?

NCT05216367 is sponsored by Hutchmed.

What drugs are being tested in NCT05216367?

Interventions in NCT05216367: Fruquintinib.

What condition does NCT05216367 study?

NCT05216367 studies Hepatic Impairment.

Is NCT05216367 still recruiting?

NCT05216367 is currently completed. Last updated 31 October 2022.

Last reviewed 2022-10-31 · How we verify

NCT05216367

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fruquintinib Hepatic Impairment Study

Completed Phase 1 Last updated 31 October 2022

What this trial tests

Phase 1 trial testing Fruquintinib in Hepatic Impairment in 16 participants. Completed in 25 October 2022.

Timeline

11 March 2022

Primary endpoint
25 October 2022

25 October 2022

Quick facts

Lead sponsor	Hutchmed
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	16
Start date	11 March 2022
Primary completion	25 October 2022
Estimated completion	25 October 2022
Sites	2 locations across United States

Drugs / interventions tested

Fruquintinib — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Hutchmed — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of Hepatic or Renal Impairment on Pharmacokinetics of Fruquintinib.
Gonzalez M, Yang Z, Schelman W, Marbury TC, et al · · 2025 · PMID 40346878 · DOI 10.1002/jcph.70040

Verify or expand the search:

Other trials of Fruquintinib

Trials testing the same drug.

NCT07510932 — Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients · Phase 2 · not yet recruiting
NCT07502014 — A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruqui · Phase 2 · not yet recruiting
NCT07124858 — Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metast · NA · not yet recruiting
NCT07446465 — FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectab · Phase 4 · not yet recruiting
NCT07235293 — A Study to Test DSP107 in Combination With Atezolizumab in Comparison With Fruquintinib as a New Treatment for Colorecta · Phase 2 · recruiting

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Hutchmed trials

Trials by the same sponsor.

NCT07409428 — A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL · Phase 3 · recruiting
NCT07396584 — HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor · Phase 1, PHASE2 · recruiting
NCT07228247 — A Phase Ⅰ/Ⅱa Study of HMPL-A251 in Participants With Advanced or Metastatic HER2-expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07348133 — Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets · Phase 1 · completed
NCT07331194 — Pharmacokinetics and Bioequivalence Study of HMPL-523 Acetate Tablets in Humans · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05216367 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hutchmed
Last refreshed: 31 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05216367.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing