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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906191
• Other study ID #: 3193A1-1114
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2009
• Last updated: August 25, 2009
• Start date: May 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SAM-531

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No