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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00823745
First received: January 7, 2009
Last updated: March 6, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
HCV
 Drug: [14C]-PF-00868554
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The amount of radioactivity recovered in urine and feces, as a percent of the dose. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
[14C]-PF-00868554
 Drug: [14C]-PF-00868554
solution, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, healthy volunteers.

Exclusion Criteria:

  • Females.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823745

Locations
United States, Washington
Pfizer Investigational Site
Tacoma, Washington, United States, 98415
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00823745     History of Changes
Other Study ID Numbers: A8121013
Study First Received: January 7, 2009
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013