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

HCV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823745
• Other study ID #: A8121013
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2009
• Last updated: March 6, 2009
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male, healthy volunteers.

Exclusion Criteria:

• Females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HCV

Intervention

Drug:
• [14C]-PF-00868554
solution, single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of radioactivity recovered in urine and feces, as a percent of the dose.		7 weeks	No
Primary	The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.		7 weeks	No
Primary	Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.		7 weeks	No
Primary	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	No
Secondary	Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.		7 weeks	Yes

External Links

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