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Study To Assess The Impact Of Hepatic Impairment On The Safety, Tolerability And Pharmacokinetics Of Single-Dose 200 Mg Of PF-868554

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ClinicalTrials.gov Identifier: NCT00651027
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HEPATITIS C (HCV) Drug: PF-868554 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study, To Evaluate The Pharmacokinetics, Safety And Toleration Of A Single Oral Dose Of Pf-00868554 In Subjects With Hepatic Impairment To Subjects With Normal Hepatic Function
Study Start Date : February 2008
Primary Completion Date : September 2008
Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: A Drug: PF-868554
200 mg, Child-Pugh Class A
Experimental: B Drug: PF-868554
200 mg, Child-Pugh Class B
Experimental: C
200 mg
Drug: PF-868554
200 mg, healthy volunteers



Primary Outcome Measures :
  1. PK parameters [ Time Frame: 8 day ]

Secondary Outcome Measures :
  1. safety and tolerability [ Time Frame: 8days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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);

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651027


Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Anaheim, California, United States, 92804
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00651027     History of Changes
Other Study ID Numbers: A8121004
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases