A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)

All subjects must meet all of the following criteria to be included in this study:

1. Male or female subjects aged 18 to 70, inclusive

2. BMI greater than or equal to 18 to lesser than or equal to 35 kg/m2, inclusive

3. Non-smokers and smokers who smoke no more than 10 cigarettes per day

4. All females must have a negative serum beta human chorionic gonadotropin (B-hCG) test result and a negative urine pregnancy test result at Screening and Baseline. Females of childbearing potential must agree to use a highly effective method of contraception (e.g., abstinence, an intrauterine device \[IUD\], a barrier method such as a condom plus spermicide or condom plus diaphragm with spermicide, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal females (defined as at least 12 months' consecutive amenorrhea, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.

5. Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential, must use, or their partners must use, a highly effective method of contraception (e.g., condom plus spermicide, condom plus diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug.

6. Voluntarily provide written informed consent prior to any study procedures

7. Are willing and able to comply with all aspects of the protocol for the duration of the study.

1. Subjects must have a diagnosis of liver cirrhosis that has been stable, without any change in disease status, for 60 days prior to study screening, as determined by the investigator.

2. Subjects must have a platelet count greater than 30,000 cells/mm3; if platelet count is lesser than 30,000 cells/mm3, the subject may be enrolled with joint approval of the principal investigator (PI) and medical monitor based on subject history and stability.

3. Subjects must have no history of clinically relevant disease or condition (e.g., significant cardiac or renal dysfunction, diseases of the gastrointestinal tract or conditions which may impact drug absorption), as determined by the investigator.

4. Subjects must have a total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild impairment), 7 to 9 (Group 2, moderate impairment), and 10 to 15 (Group 3, severe impairment).

5. Subjects with a history of Type I or Type II diabetes are permissible, providing that, in the opinion of the investigator, they have stable disease. Subjects receiving insulin therapy are permissible provided that they have been on a stable treatment for at least 2 weeks prior to study enrollment and continuing through the study.

What this study is about