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Trial record 1 of 1 for:    NCT00906191
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Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects

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ClinicalTrials.gov Identifier: NCT00906191
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : August 26, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE May 11, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date August 26, 2009
Study Start Date  ICMJE May 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
Radioactivity measurements in blood, urine and feces and pharmacokinetic parameters (Cmax, AUC, terminal elimination half life, total clearance and volume of distribution in the plasma ; urine clearance ; metabolite profiling in plasma, urine and feces.) [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00906191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects
Official Title  ICMJE An Open-Label, Single-Dose, Nonrandomized Study Of The Mass Balance And Metabolic Disposition Of Orally Administered 14C-Labeled SAM-531 In Healthy Male Subjects
Brief Summary The objective of this study is to investigate how quickly and to what extent the 14-Carbon labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is radioactive, this enables the compound to be traced in blood, urine and feces.
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: Health Services Research
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: SAM-531
Study Arms  ICMJE Experimental: 1
Single oral dose
Intervention: Drug: SAM-531
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
 (submitted: May 19, 2009)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged 18 to 50 years inclusive at screening
  • Healthy as determined by the investigator on the basis of screening evaluations

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00906191
Other Study ID Numbers  ICMJE 3193A1-1114
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

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