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Completed

NCT Number: NCT01051232

A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) 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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active

Drug

Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.

Placebo

Drug

Two subjects will receive the placebo under fasting condition.

Primary outcomes

  1. Safety; ECGs/vital signs

    Time frame: Screening to Follow-up (Day 5)

  2. Safety; laboratory tests

    Time frame: Screening to Follow-up (Day 5)

  3. Safety; physical examination/adverse event monitoring

    Time frame: Screening to Follow-up (Day 5)

Secondary outcomes

  1. Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations

    Time frame: Day 1 to Day 3

  2. Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations

    Time frame: Day 1 to Day 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2010
Registry last updated
Apr 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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