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Completed

NCT Number: NCT00823745

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

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.

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Key information

Conditions

HCV

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Tacoma, Washington, 98415, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, healthy volunteers.

Exclusion criteria

  • Females.

Treatment and study plan

[14C]-PF-00868554

Drug

solution, single dose

Primary outcomes

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

    Time frame: 7 weeks

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

    Time frame: 7 weeks

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

    Time frame: 7 weeks

  4. 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.

    Time frame: 7 weeks

Secondary outcomes

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

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 16, 2009
Registry last updated
Mar 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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