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

Launched by EISAI CO., LTD. · Feb 13, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how a medication called tasurgratinib (E7090) behaves in the body of people with mild and moderate liver issues, compared to healthy individuals. The main goal is to see how the liver's condition affects the way this drug is processed after a single dose. Researchers are currently looking for participants, including those with stable liver impairment and healthy individuals, to help them gather this important information.

To be eligible for the study, participants must be between 18 and 40 years old and have a Body Mass Index (BMI) between 18 and 40. Those in the liver impairment groups need to have a stable condition classified as Child-Pugh A or B, while healthy participants will be matched to those with liver issues based on age, weight, race, and gender. Participants can expect to undergo various health assessments and monitoring during the study to ensure their safety. It’s important to note that people with certain eye disorders, HIV, or specific heart conditions will not be able to take part in the trial. This study will help researchers better understand how liver health affects the treatment options available for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m\^2).
• • 2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.
• • 3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20 percent \[%\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations.
• Exclusion Criteria:
• Key Exclusion for all Participants:
• • 1. Following ocular disorders
• • 1. Current evidence of Grade 2 or higher corneal disorder
• • 2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)
• • 2. Known to be human immunodeficiency virus (HIV) positive at Screening.
• • 3. A prolonged QT/QTc interval (\[QT interval using Fridericia's formula\] QTcF greater than (\>) 480 millisecond \[ms\]) demonstrated on ECG.
• • Additional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)
• In addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:
• • 1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.
• • 2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy
• • 3. The participant's standard therapy/concomitant medication for diseases related to hepatic disease has not remained stable/unchanged for at least two weeks before dosing of study drug.
• • Additional Exclusion Criteria for Healthy participants (Cohort C)
• In addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include:
• • 1. Syphilis as demonstrated by positive serology at Screening.
• • 2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.