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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
HCVRadiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
NCT00823745
- Tacoma, Washington
Male
18 Years+
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 | ||||