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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00726115
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: SAM-531; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Dose of SAM-531 Administered Orally To Healthy Young and Elderly Subjects
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 arm placebo	Drug: SAM-531
Experimental: 2 arm drug	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics, routine Lab tests, Vital signs, ECG [29 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Rueil Malmaison		France	92502

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00726115
• Other Study ID Numbers: 3193A1-1111
• First Posted: Jul 31, 2008
• Last Update Posted: Jul 30, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jul 30, 2009