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CompletedNCT00651027Updated Jan 3, 2014

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

A Phase 1 interventional study of PF-868554 and PF-868554 in HEPATITIS C (HCV), sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years to 62 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-03.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 62 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HEPATITIS C (HCV)

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03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 24 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

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Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    A

    Drug: PF-868554

  • Experimental
    B

    Drug: PF-868554

  • Experimental
    C

    200 mg

    Drug: PF-868554

Interventions

  • DrugPF-868554

    200 mg, Child-Pugh Class A

  • DrugPF-868554

    200 mg, Child-Pugh Class B

  • DrugPF-868554

    200 mg, healthy volunteers

06

What researchers measure

Primary outcomes

  1. PK parameters

    Time frame: 8 day

Secondary outcomes

  1. safety and tolerability

    Time frame: 8days

07

Study locations

3 sites
  • Pfizer Investigational Site
    Anaheim, California 92801, United States
  • Pfizer Investigational Site
    Anaheim, California 92804, United States
  • Pfizer Investigational Site
    Miami, Florida 33169, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00651027
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Apr 2, 2008
Start date
Feb 2008
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Jan 3, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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