NCT00875628

Brief Summary

Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

Trial Health

57
Monitor

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-volunteers

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

Enrollment Period

Same day

First QC Date

April 1, 2009

Last Update Submit

October 21, 2009

Conditions

Healthy Volunteers

Keywords

Japanese Healthy volunteers HCV pharmacokinetics PF-00868554 filibuvir

Outcome Measures

Primary Outcomes (5)

  • Plasma PF-00868554 concentrations

    Day 1-Day 17

  • Urine PF-00868554 concentrations

    Day 1 and Day 14

  • Adverse event monitoring and Physical examination

    Day 0-Day 17

  • ECGs and vital signs (Blood pressure and Pulse rate)

    Day 1-Day 17

  • Clinical safety laboratory tests

    Day 0, Day 7, and Day 17

Study Arms (3)

Cohort 1

OTHER

PF-00868554 100 mg or placebo

Drug: PF-00868554 or Placebo

Cohort 2

OTHER

PF-00868554 300 mg or placebo

Drug: PF-00868554 or Placebo

Cohort 3

OTHER

PF-00868554 600 mg or placebo

Drug: PF-00868554 or Placebo

Interventions

PF-00868554 or PlaceboDRUG

Dosage Form: Oral solution Dosage: PF-00868554 100 mg or placebo under fasting conditions Frequency: BID (twice daily) Duration: 14 days

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female Japanese subjects between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

You may not qualify if:

  • Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
  • Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
  • Pregnant or nursing females; females of childbearing potential.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

MeSH Terms

Interventions

filibuvir

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 3, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

US(1)