Status:
COMPLETED
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Lead Sponsor:
Pfizer
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Hepatic impairment PK study
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03309202
Start Date
December 19 2017
End Date
July 18 2018
Last Update
August 8 2019
Active Locations (6)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
3
Pharmaceutical Research Associates CZ, s.r.o.
Prague, Czechia, 170 00
4
Nemocnice Na Bulovce
Prague, Czechia, 180 81