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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 22, 2014