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Tracking Information | |||||
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First Received Date † | September 28, 2007 | ||||
Last Updated Date | October 30, 2008 | ||||
Start Date † | October 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00537615 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Pharmacokinetic analysis of metabolites if detectable | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | An Open-Label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers | ||||
Official Title † | A Phase 1 Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0332334 In Six Healthy Male Volunteers | ||||
Brief Summary | The purpose of this study is to investigate the absorption, metabolism and excretion of [14C] PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any metabolites of [14C] PD 0332334. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study | ||||
Condition † | Anxiety Disorders | ||||
Intervention † | Drug: PD 0332334 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 6 | ||||
Completion Date | October 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:
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Gender | Male | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00537615 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Pfizer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Pfizer | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |