Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: May 24, 2007
Last updated: July 6, 2009
Last verified: July 2009
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.

Condition Intervention Phase
Alzheimer Disease
Drug: SAM-531
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SAM 531 + placebo
Drug: SAM-531
Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  • Men aged 20 to 45 years, inclusive, at screening.
  • Elderly men or women aged 65 years and above as of screening.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
  • Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00479349

Tokyo, Japan, 170-0003
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00479349     History of Changes
Other Study ID Numbers: 3193A1-1104 
Study First Received: May 24, 2007
Last Updated: July 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on May 01, 2016