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 |
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.
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
sites
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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