Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF-05221304 IN ADULT SUBJECTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITHOUT HEPATIC IMPAIRMENT

Hepatic impairment PK study

This is a non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in the fed state.

Key Exclusion Criteria:

All subjects -

• Adults <18 years of age and >70 years of age
• BMI < 17.5 and > 35.4 kg/m2
• HIV positive
• Conditions that affect drug absorption
• Positive breath alcohol test

Healthy/ those without hepatic impairment -

• Known or suspected hepatic impairment
• Evidence of Hepatitis B or C
• On any chronic medications

Those with varying degrees of hepatic impairment -

• Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh Classification
• Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
• Recent GI bleed
• Moderate or severe renal impairment
• Hepatic encephalopathy Grade 3 or higher