CLINICAL TRIALS PROFILE FOR SETANAXIB

Clinical Trials for Setanaxib

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04327089 ↗	Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects	Completed	Genkyotex SA	Phase 1	The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and in particular the dose proportionality of setanaxib and its metabolites after a single oral dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).
NCT05014672 ↗	A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness	Not yet recruiting	Genkyotex Suisse SA	Phase 2/Phase 3	The primary objective of this study is to evaluate the effect of setanaxib on biochemical response at Week 52 in participants with primary biliary cholangitis (PBC) and with elevated liver stiffness and intolerance or inadequate response to ursodeoxycholic acid (UDCA).
NCT05323656 ↗	A Phase 2, Randomised Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic SCCHN	Recruiting	Genkyotex Suisse SA	Phase 2	The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

Clinical Trial Conditions for Setanaxib

Condition Name

Condition Name
Intervention	Trials
Liver Stiffness	1
Phase 1	1
Primary Biliary Cholangitis	1
Squamous Cell Carcinoma of Head and Neck	1

Condition MeSH

Condition MeSH
Intervention	Trials
Squamous Cell Carcinoma of Head and Neck	1
Carcinoma, Squamous Cell	1
Carcinoma	1
Liver Cirrhosis, Biliary	1

Clinical Trial Locations for Setanaxib

Trials by Country

Trials by Country
Location	Trials
France	1
Spain	1
United States	1

Trials by US State

Trials by US State
Location	Trials
Mississippi	1

Clinical Trial Progress for Setanaxib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for Setanaxib

Sponsor Name

Sponsor Name
Sponsor	Trials
Genkyotex Suisse SA	2
Genkyotex SA	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	3