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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: PF-05221304

Study type: Interventional

Funder types: Industry

Identifiers

NCT03309202

C1171006

2017-003034-86 (EudraCT Number)

Details and patient eligibility

About

Hepatic impairment PK study

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Cohort 1_Without impairment

Experimental group

Description:

Single, 25 mg dose of PF-05221304

Treatment:

Drug: PF-05221304

Cohort 2_Mild impairment

Experimental group

Description:

Single, 25 mg dose of PF-05221304

Treatment:

Drug: PF-05221304

Cohort 3_Moderate impairment

Experimental group

Description:

Single, 25 mg dose of PF-05221304

Treatment:

Drug: PF-05221304

Cohort 4_Severe impairment

Experimental group

Description:

Single, 25 mg dose of PF-05221304

Treatment:

Drug: PF-05221304