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

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Eisai Inc.
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Updated on 19 February 2024
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body mass index
electrocardiogram
electrocardiogram (ecg)
hepatic impairment
moderate hepatic impairment
moderate hepatic insufficiency
e7090

Summary

The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of E7090 after a single dose administration.

Details
Condition Hepatic Impairment
Age 20-64 years
Treatment E7090
Clinical Study IdentifierNCT04271488
SponsorEisai Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m^2)
For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B
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
Following ocular disorders
Current evidence of Grade 2 or higher corneal disorder
Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)
Known to be human immunodeficiency virus (HIV) positive at Screening
A prolonged QT/QTc interval ([QT interval using Fridericia's formula] QTcF greater than (>) 480 millisecond [ms]) demonstrated on ECG
Participants who need the use of drugs or foods that strongly inhibits or induces the metabolizing enzyme Cytochrome P450, family 3, subfamily A (CYP3A)
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
Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing
Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy
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
Syphilis as demonstrated by positive serology at Screening
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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