Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects
- Registration Number
- NCT00906191
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SAM-531 Single oral dose
- Primary Outcome Measures
Name Time Method 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.) 15 days
- Secondary Outcome Measures
Name Time Method