A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects

This is a multi-center, open-label, parallel-arm study in 1 group of subjects with normal
hepatic function and 3 groups of subjects with varying degrees of hepatic impairment (mild,
moderate, and severe). Subjects will be confined to the clinic from Day -1 to Day 8.
Subjects will be contacted via telephone 30 days (+ 2 days) after the last dose of study
medication to assess any new or ongoing AEs and to record concomitant medications. All
groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature
still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least
8 hours of fasting) and no food will be allowed for 4 hours postdose.

Inclusion Criteria:

- Males and females of non-childbearing potential ≥ 18 years of age

- Body weight within ± 30% of ideal body weight as defined in the 1983 Metropolitan
Height and Weight Tables. Minimum body weight no less than 50 kg.

- Able to provide written, informed consent.

- Male and female subjects who are surgically sterile; female subjects who have been
postmenopausal for at least 12 consecutive months; or male subjects who agree to
remain abstinent or to practice double-barrier forms of birth control and refrain
from sperm donation from Screening through 90 days from the last dose of study
medication.

Inclusion Criteria for Hepatically Impaired Subjects Only:

- Hepatically impaired subjects with creatinine clearance (CLcr) > 30 mL/min.

- Subjects with hepatic impairment should have relatively stable hepatic function for
the duration of the study, and otherwise be in generally good health.

- A clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.

- Child-Pugh Class A (mild), B (moderate), or C (severe)

- Hepatically impaired subjects may be taking medications, which in the opinion of the
clinical investigator and sponsor, are believed to be therapeutic for the subjects.

- Hepatically impaired subjects may have a history of or current hepatitis or be
carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies
(anti-HC).

Inclusion Criteria for Subjects with Normal Hepatic Function Only

- Must be in good health as determined by medical history, physical examination, ECG,
serum/urine biochemistry, hematology, and serology tests.

- Normal renal function as evidenced by CLcr that is within 20% of normal for the age,
sex, and weight of the individual.

Exclusion Criteria:

- History of drug and/or alcohol abuse within 2 years prior to Screening.

- History of acquired immunodeficiency syndrome or human immunodeficiency virus (HIV)
antibodies.

- History of any significant drug allergy or known or suspected hypersensitivity.

- A positive urine alcohol test and/or urine drug screen for substance of abuse at
Screening or upon admission to the study center.

- Subjects having taken an investigational drug within 30 days preceding study entry.

- Any history of significant bleeding or hemorrhagic tendencies. Subjects with a
history of bleeding tendencies secondary to hepatic impairment will not be excluded.

- A history of difficulty in donating blood.

- The donation of blood or plasma within 30 days prior to dosing.

- Consumption of alcohol and/or food and beverages containing methylxanthines,
grapefruit, grapefruit juice, Seville oranges, or Seville orange juice within 72
hours prior to dosing.

- Exposure to any substances known to stimulate hepatic microsomal enzymes within 30
days prior to Screening through the end of the study.

- Subjects who have supine, sitting, or standing blood pressure, after resting for ≥ 3
minutes, higher than 140/90 mmHg or lower than 100/50 mmHg.

- Subjects who have a supine pulse rate, after resting for ≥ 3 minutes, outside the
range of 40 to 90 bpm.

- Previous exposure to OPC-34712.

- Subjects who are pregnant or breastfeeding.

- Subjects with a QTcF interval ≥ 450 msec.

- Subjects with PT greater than 2 times control. Subjects with hepatic impairment with
prolonged PT will be excluded based on the PI's discretion.

- Subjects with hepatic carcinoma or porto-hepatic shunts that have been surgically
created or planted.

- Partial thromboplastin time > 70 seconds.

Exclusion Criteria for Hepatically Impaired Subjects Only:

- History of serious mental disorder including subjects who are pre-encephalopathic or
encephalopathic as assessed by the Child-Pugh score and/or the PI's judgment.

- Major surgery of the digestive tract.

Exclusion Criteria for Subjects with Normal Hepatic Function Only:

- Clinically significant abnormality in past medical history.

- History of or current hepatitis, or carriers of HBsAg and/or anti-HC.

- Use of prescription, over-the-counter, herbal medication or vitamin supplements
within 14 days prior to dosing and antibiotics within 30 days prior to dosing.

- History of serious mental disorders.

- Major surgery of the digestive tract (excluding appendectomy).