Recruiting PHASE1 Patients With Mild or Moderate Hepatic Impairment

New treatment option for Patients With Mild or Moderate Hepatic Impairment

Official title A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment

ClinicalTrials.gov ID: NCT07231029

What this study is testing

What is TS-172?

TS-172 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for patients with mild or moderate hepatic impairment.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent
  • Patients with chronic hepatic impairment
  • Patients who were classified by the principal investigator or sub-investigator as Class A (mild) or Class B (moderate) by Child-Pugh classification...
  • Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent
  • people whose body mass index is \>=18.5 and \<35.0 at the screening test Other protocol defined could apply. \<

You likely can't join if

  • for patients with hepatic impairment\>
  • Patients with medical history of liver resection or liver transplantation
  • Patients with grade II or higher hepatic encephalopathy
  • Patients whose eGFR is \
  • people with current condition or medical history of diseases that are ineligible for participation in the study
  • people whose eGFR is \<60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.

The study team makes the final eligibility decision.

Where it's taking place

  • Tokyo, Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.