An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and its Metabolite in Subjects with Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
- Conditions
- Participants with hepatic impairment
- Registration Number
- JPRN-jRCT2080225113
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 18
1. BMI between 18 to 40 kg/m2.
2. For participants with hepatic Impairment: stable hepatic impairment conforming to Child-Pugh classification A and B.
3. For Healthy subjects: matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20%), race and gender.
[Hepatic impairment Cohort]
1.Any significant acute medical illness, such as new conditions or the exacerbation of pre-existing conditions, within 8 weeks of dosing.
2.Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy.
3.The subject's standard therapy/concomitant medication for diseases related to hepatic impairment has not remained stable/unchanged for at least 2 weeks prior to dosing.
[Healthy subject Cohort]
1.Subjects tested positive for syphilis (qualitative).
2.Any abnormal finding based on physical examination, assessment of vital signs, and ECG, or laboratory test results that requires treatment or clinical follow-up based on the investigator's opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics, drug concentration, pharmacokinetic parameter
- Secondary Outcome Measures
Name Time Method safety