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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

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

Eisai Co., Ltd.

4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan

eisai-chiken_hotline@hhc.eisai.co.jp

Eisai Co., Ltd.

4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan

+81-3-3817-5252

eisai-chiken_hotline@hhc.eisai.co.jp

recruiting

Feb. 27, 2020

Interventional

Open(masking not used), Parallel assignment

treatment purpose

1

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.

Both

Participants with hepatic impairment

investigational material(s)
Generic name etc: E7090
Dosage and Administration for Investigational material:E7090 35mg (participants with mild hepatic impairment and healthy subjects) and 10 mg (participants with moderate hepatic impairment) single oral dose under fasted condition

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

pharmacokinetics, drug concentration, pharmacokinetic parameter

safety

Feb. 21, 2020