Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 sites80 target enrollmentStarted: May 2006Last updated: December 10, 2007

ConditionsAlzheimer Disease

DrugsSAM-531

Overview

Phase: Phase 1
Status: Completed
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 80
Primary Endpoint: Safety and tolerability

Overview Study Design Eligibility Criteria Outcomes Investigators Records & Identifiers Similar Trials

Overview

Brief Summary

To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-531 administered to healthy subjects.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Safety and tolerability

Secondary Outcomes

Pharmacokinetics and pharmacodynamics

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Sponsor Class

Industry

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