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
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.

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.

4. 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:

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.