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

Tracking Information

First Received Date ^ICMJE

January 7, 2009

Last Updated Date

March 6, 2009

Start Date ^ICMJE

January 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00823745 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

HCV

Intervention ^ICMJE

Drug: [14C]-PF-00868554

solution, single dose

Study Arm (s)

Experimental: 1

[14C]-PF-00868554

Intervention: Drug: [14C]-PF-00868554

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male, healthy volunteers.

Exclusion Criteria:

Females.

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00823745

Other Study ID Numbers ^ICMJE

A8121013

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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