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Actively Recruiting

Phase 1
Age: 20Years - 79Years
All Genders
Healthy Volunteers
ID04271488

Study of Tasurgratinib Drug Levels in Adults With Mild or Moderate Liver Problems Compared to Healthy Adults

Led by Eisai Co., Ltd. · Updated on 2026-01-23

18

Participants Needed

8

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying how mild and moderate liver impairment affect the way the body processes tasurgratinib after a single dose. This Phase 1 study compares participants with liver impairment to healthy individuals matched by age, race, gender, and body weight to better understand the drugs behavior in these groups. Participants with mild liver impairment receive a single 35 mg tablet of tasurgratinib after fasting overnight. Those with moderate impairment take a lower dose of 10 mg as two 5 mg capsules under the same fasting conditions. Healthy participants receive a 35 mg tablet and serve as a control group to compare drug effects. During the study, participants are monitored for how much tasurgratinib and its metabolites appear in their blood over 144 hours after dosing. Researchers measure peak concentrations, total drug exposure, time to peak, half-life, clearance, and volume of distribution. Safety tests include physical exams, ECGs, and lab tests. The study aims to complete by November 2026.

CONDITIONS

Brief Title

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

Research Team

I

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