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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:11/18/2018
Start Date:December 19, 2017
End Date:July 18, 2018

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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
We found this trial at
2
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Brussels,
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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