Table 1.

Cohort Definitions

Cohort Description	Hepatic	Renal
Normal organ function	Cohort 1: Total bilirubin ≤ ULN and AST ≤ ULN and CrCl ≥ 60 mL/min
Mild dysfunction	Cohort 2: Bilirubin > ULN but ≤ 1.5× ULN and/or AST > ULN	Cohort 3: CrCl between 40 and 59 mL/min
Moderate dysfunction	Cohort 4: Bilirubin > 1.5× ULN to ≤ 3× ULN and any AST	Cohort 5: CrCl between 20 and 39 mL/min
Severe dysfunction	Cohort 6: Bilirubin > 3× ULN to 10× ULN and any AST	Cohort 7: CrCl < 20 mL/min
Very severe dysfunction	Cohort 8: Albumin < 2.5 mg/dL, any bilirubin, and any AST	Cohort 9: Hemodialysis, any CrCl

Abbreviations: ULN, upper limit of normal; CrCl, creatinine clearance.