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

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

Sponsors

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

Source 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.

Overall Status Completed
Start Date May 2009
Completion Date August 2009
Primary Completion Date August 2009
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Enrollment 6
Condition
Intervention

Intervention Type: Drug

Intervention Name: SAM-531

Arm Group Label: 1

Eligibility

Criteria:

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.

Gender: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Location
Facility:
Location Countries

Netherlands

Verification Date

August 2009

Responsible Party

Name Title: Wyeth (Registry Contact: Clinical Trial Registry Specialist)

Organization: Wyeth

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 1

Type: Experimental

Description: Single oral dose

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov