Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531

Alzheimer Disease Clinical Trial

Official title:

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726115
• Other study ID #: 3193A1-1111
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2008
• Last updated: July 29, 2009
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: July 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 main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.

• history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria:

• Presence or history of any disorder that may prevent the successful completion of the study.

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SAM-531

• placebo

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

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics, routine Lab tests, Vital signs, ECG		29 days	No