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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01051232

Enrollment

Registered

2010-01-18

Start date

2010-02-28

Completion date

2010-04-30

Last updated

2010-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

filibuvir, pharmacokinetics, Japanese, Asian

Brief summary

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.

Detailed description

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

Interventions

DRUGActive

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

DRUGPlacebo

Two subjects will receive the placebo under fasting condition.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026