Study Evaluating Safety, Tolerability and Pharmacokinetics of Single and Multiple Dose of SAM-531

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: placebo; Drug: SAM-531

Study type: Interventional

Funder types: Industry

Identifiers

NCT00726115

3193A1-1111

Details and patient eligibility

About

The main objectives of this study is to assess the safety and tolerability of ascending single and multiple oral doses of SAM-531 in healthy subjects

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Body weight for elderly subjects must be greater than or equal to 45 kg.
• history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic or psychiatric disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

arm placebo

Treatment:

Drug: SAM-531

2

Experimental group

Description:

arm drug

Treatment:

Drug: placebo