NCT00823745

Brief Summary

This is a phase 1 study to assess the routes of elimination of a single oral dose of \[14C\] PF-00868554 and to characterize the metabolic profile following single dose administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

January 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

January 7, 2009

Last Update Submit

March 6, 2009

Conditions

HCV

Outcome Measures

Primary Outcomes (4)

  • The amount of radioactivity recovered in urine and feces, as a percent of the dose.

    7 weeks

  • The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.

    7 weeks

  • Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.

    7 weeks

  • PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.

    7 weeks

Secondary Outcomes (1)

  • Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.

    7 weeks

Study Arms (1)

1

EXPERIMENTAL

\[14C\]-PF-00868554

Drug: [14C]-PF-00868554

Interventions

[14C]-PF-00868554DRUG

solution, single dose

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male, healthy volunteers.

You may not qualify if:

  • Females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Tacoma, Washington, 98415, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations

US(1)