NCT00651027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

March 31, 2008

Last Update Submit

January 2, 2014

Conditions

HEPATITIS C (HCV)

Outcome Measures

Primary Outcomes (1)

  • PK parameters

    8 day

Secondary Outcomes (1)

  • safety and tolerability

    8days

Study Arms (3)

A

EXPERIMENTAL
Drug: PF-868554

B

EXPERIMENTAL
Drug: PF-868554

C

EXPERIMENTAL

200 mg

Drug: PF-868554

Interventions

PF-868554DRUG

200 mg, Child-Pugh Class A

A

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

Anaheim, California, 92804, United States

Location

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

filibuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

US(3)