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Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
Tokyo, , 170-0003 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00479349
Pfizer
Completed
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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