Back to results

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

Primary Purpose

HEPATITIS C (HCV)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-868554

About this trial

This is an interventional treatment trial for HEPATITIS C (HCV)

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

200 mg

Outcomes

Primary Outcome Measures

PK parameters

Secondary Outcome Measures

safety and tolerability

Full Information

NCT ID

NCT00651027

First Posted

March 31, 2008

Last Updated

January 2, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00651027

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HEPATITIS C (HCV)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Description

200 mg

Intervention Type

Drug

Intervention Name(s)

PF-868554

Intervention Description

200 mg, Child-Pugh Class A

Intervention Type

Drug

Intervention Name(s)

PF-868554

Intervention Description

200 mg, Child-Pugh Class B

Intervention Type

Drug

Intervention Name(s)

PF-868554

Intervention Description

200 mg, healthy volunteers

Primary Outcome Measure Information:

Title

PK parameters

Time Frame

8 day

Secondary Outcome Measure Information:

Title

safety and tolerability

Time Frame

8days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

62 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121004&StudyName=Study%20To%20Assess%20The%20Impact%20Of%20Hepatic%20Impairment%20On%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20Single-Dose%20200%20Mg%20Of%20PF-868554

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs