NCT01051232

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.

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 healthy

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

Enrollment Period

2 months

First QC Date

January 14, 2010

Last Update Submit

April 22, 2010

Conditions

Healthy

Keywords

filibuvirpharmacokineticsJapaneseAsian

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations

    Day 1 to Day 3

  • Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations

    Day 1 to Day 3

Study Arms (3)

Cohort 1

PLACEBO COMPARATOR

PF-00868554 (filibuvir) 100 mg or placebo

Drug: ActiveDrug: Placebo

Cohort 2

PLACEBO COMPARATOR

PF-00868554 (filibuvir) 300 mg or placebo

Drug: ActiveDrug: Placebo

Cohort 3

PLACEBO COMPARATOR

PF-00868554 (filibuvir) 500 mg or placebo

Drug: ActiveDrug: Placebo

Interventions

ActiveDRUG

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

Cohort 1
PlaceboDRUG

Two subjects will receive the placebo under fasting condition.

Cohort 1

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 18, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 26, 2010

Record last verified: 2010-04

Locations

JP(1)