A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers

April 22, 2010 updated by: Pfizer

A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers

A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female subjects between the ages of 20 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

  • A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
  • Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
  • Pregnant or nursing females; females of childbearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Placebo Comparator: Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Placebo Comparator: Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Drug: Placebo
Two subjects will receive the placebo under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Drug: Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety; ECGs/vital signs
Time Frame: Screening to Follow-up (Day 5)
Screening to Follow-up (Day 5)
Safety; laboratory tests
Time Frame: Screening to Follow-up (Day 5)
Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring
Time Frame: Screening to Follow-up (Day 5)
Screening to Follow-up (Day 5)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
Time Frame: Day 1 to Day 3
Day 1 to Day 3
Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
Time Frame: Day 1 to Day 3
Day 1 to Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 18, 2010

Study Record Updates

Last Update Posted (Estimate)

April 26, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A8121035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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