Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554
Phase 1
Completed
- Conditions
- HEPATITIS C (HCV)
- Interventions
- Drug: PF-868554
- Registration Number
- NCT00651027
- Lead Sponsor
- Pfizer
- Brief Summary
The metabolism of PF-00868554 is primarily mediated by CYP3A, and it is anticipated that hepatic impairment will modify PF-00868554 plasma concentrations. Hence, it is important to determine the impact of varying degrees of hepatic impairment on the pharmacokinetics, safety and toleration of 200 mg PF-00868554 administered as a single-dose.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Male or females subjects of non-childbearing potential between the ages of 18 and 62 years of age, inclusive;
- Body Mass Index (BMI) of approximately 18 to 35 kg/m2; and a total body weigh >50 kg (110 lbs);
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Exclusion Criteria
- Subjects with Class C classification (Severe - Child-Pugh Scores greater than 10);
- Severe ascites and/or pleural effusion;
- Had a transplanted kidney, heart or liver;
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A PF-868554 - B PF-868554 - C PF-868554 200 mg
- Primary Outcome Measures
Name Time Method PK parameters 8 day
- Secondary Outcome Measures
Name Time Method safety and tolerability 8days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Miami, Florida, United States