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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: SAM-531

Study type: Interventional

Funder types: Industry

Identifiers

NCT00906191

3193A1-1114

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Description:

Single oral dose

Treatment:

Drug: SAM-531