NCT00479297
Completed
Phase 1
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 sites72 target enrollmentStarted: May 2006Last updated:
ConditionsAlzheimer Disease
DrugsSAM-531
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 72
- Primary Endpoint
- Safety and tolerability
Overview
Brief Summary
To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and tolerability
Secondary Outcomes
- Pharmacokinetics and pharmacodynamics
Investigators
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