Alzheimer Disease
Conditions
Brief summary
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.
Interventions
DRUGSAM-531
Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics | 9 months |
Countries
Japan
Outcome results
None listed