Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects

A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00823745

Enrollment

Registered

2009-01-16

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2009-03-09

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

Conditions

HCV

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.

Interventions

DRUG[14C]-PF-00868554

solution, single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Male, healthy volunteers.

Exclusion criteria

* Females.

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.	7 weeks

Countries

United States

Outcome results

None listed

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