Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Inclusion Criteria:

- Hepatically impaired groups:

- Agree to doctor approved birth control methods from Day 1 until 3 months
following the final dose of study drug.

- Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A,
score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score
Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment
Score Grade C, score 10-15);

- Control group

- Agree to doctor approved birth control methods from Day 1 until 3 months
following the final dose of study drug.

- Healthy as determined by medical history, physical exam, vital signs, ECGs, and
clinical laboratory tests.

Exclusion Criteria:

- Hepatically impaired groups:

- Have used any drugs known to significantly affect hepatic metabolism within 28
days, or is unable or unwilling to forgo the use of such products throughout the
study;

- Have any acute or unstable condition or disease, other than impaired hepatic
function, as determined by medical history, physical exam, ECG and clinical
laboratory tests;

- Known ongoing alcohol and/or drug abuse within 1 month

- Any evidence of progressive worsening liver function disease as indicated by
laboratory values;

- Have had an acute flare of hepatitis A or B within 6 months;

- Have acute, fulminant alcoholic hepatitis, determined either clinically or by
histology;

- Have a history of hepatoma or metastatic disease of the liver;

- Control group:

- Have used any drugs known to significantly affect hepatic metabolism within 28
days, or is unable or unwilling to forgo the use of such products throughout the
study;

- Have a history or presence of clinically cardiovascular, dermatologic,
endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic,
oncologic, psychiatric, pulmonary, or renal disease or any other condition.