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.