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Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects

Last updated on February 20, 2019

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Study Location
Rennes, , 35000 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men or women of nonchildbearing potential aged 18 to 45 years

- Elderly men or women aged 65 years and above as of study day 1.

- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for
elderly subjects must be ≥45 kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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, digital 12-lead ECGs, or clinical laboratory test results.

- Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea,
chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or
grapefruit or grapefruit-containing products 72 hours before study day 1, and until
the end of the inpatient confinement period.

- Elderly men or women aged 65 years and above as of study day 1.

- Body mass index in the range of 18 to 30 kg/m2 and body weight ?50 kg. Body weight for
elderly subjects must be ?45 kg.

NCT00480818
Pfizer
Completed
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects

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