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Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults

Last updated on March 14, 2019

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Study Location
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
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men and women of nonchildbearing potential aged 18 to 45 years

- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

- 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 (e.g., coffee, tea, chocolate, or
soda) or alcoholic beverages within 48 hours and, grapefruit, grapefruit-containing
products is prohibited 72 hours before study day 1.

NCT00479440
Pfizer
Completed
Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults

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[email protected]

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