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A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)

Last updated on March 15, 2019

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Study Location
California Clinical Trials Medical Group, Inc.
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male and/or female subjects of non childbearing potential

- BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)

- Evidence of a personally signed and dated informed consent document indicating that
subject has been informed of all pertinent aspects of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated asymptomatic,
seasonal allergies at the time of dosing)

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer)

- Subjects with a history of significant active bleeding, coagulation disorder or
clinically significant finding on prothrombin time/ partial thromboplastin
time/International Normalized Ratio (PT/PTT/INR) at Screening

- Subjects with lower spinal malformations (on physical examination), local spinal
infection, or other abnormalities that would exclude puncture (LP)

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study

NCT02407353
Pfizer
Completed
A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)

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[email protected]

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