Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
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.
|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|
- Safety and tolerability [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Pharmacokinetics and pharmacodynamics [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
SAM 531 + placebo
Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.