Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
NCT00823745
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HCV
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Male, healthy volunteers.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Females.
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HCVRadiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
NCT00823745
- Tacoma, Washington
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years
MULTIPLE SITES
Advanced Information
| 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 ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | HCV | |||
| Intervention ICMJE | Drug: [14C]-PF-00868554
solution, single dose | |||
| Study Arms ICMJE | 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 | |||
| Actual Enrollment ICMJE | 7 | |||
| Original Estimated Enrollment ICMJE | 4 | |||
| Actual Study Completion Date ICMJE | February 2009 | |||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00823745 | |||
| Other Study ID Numbers ICMJE | A8121013 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||