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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males

Last updated on February 22, 2019

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Study Location
Ibaraki Pref, , 305-0856 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
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men aged 20 to 45 years (inclusive) at the time of getting informed consent.

- Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI =
[weight (kg)]/[height (m)]2).

- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital signs, and digital 12-lead
electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase
(AST) and creatinine levels must be within the upper limit of normal for eligibility.

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.

- Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola)
or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a
grapefruit-containing products is prohibited from 72 hours before study day 1.

NCT00480467
Pfizer
Completed
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males

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