Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects

NCT00906191 — Phase 1, Completed, 6 participants, Wyeth is now a wholly owned subsidiary of Pfizer

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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

Registry	NCT00906191
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, single group, masking: none, health services research
Enrollment	6 (Actual)
Sponsor	Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Conditions	Alzheimer Disease
Interventions	SAM-531 (Drug)
Dates	start 2009-05-01, primary completion 2009-08-01, completion 2009-08-01, first posted 2009-05-21, last updated 2009-08-26
Locations	1 site in Netherlands

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: SAM-531	Single oral dose

SAM-531 (Drug)

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: Male, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
	Zuidlaren	Netherlands

+Investigators

Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer