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

• Status: Completed
• Trial end date: 2018-07-18
• Target enrollment: 0
• Participant gender: All

Summary

Hepatic impairment PK study

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

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