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A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751

Last updated on February 23, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 between the ages of
18 and 55 years

- Female subjects of non childbearing potential that meet at least one of the following
criteria: Achieved postmenopausal status, defined as: cessation of regular menses for
at least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level confirming the
postmenopausal status; Have undergone a documented hysterectomy and/or bilateral
oophorectomy; Have medically confirmed ovarian failure.

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 time of dosing).

- Any condition possibly affecting drug absorption.

- Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure
threshold, seizures of any etiology (including substance or drug withdrawal), or who
have increased risk of seizures as evidenced by history of EEG with epileptiform
activity. Subjects with a history of childhood seizures, and history of head trauma
with loss of consciousness requiring hospitalization overnight will be excluded as
well.

NCT01981694
Pfizer
Completed
A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751

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[email protected]

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