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A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model

Last updated on March 15, 2019

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Study Location
(Drug Shipment Address ONLY) Duke University Health Systems (DUHS) Investigational Drug Services
Durham, North Carolina, 27710 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
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy men or women (non-childbearing potential) between the ages of 18-40 years.

- Body Mass Index (BMI) 18-30 kg/m2 and a total body weight >50 kg (110 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History or evidence of habitual use of tobacco- or nicotine-containing products within
3 months of screening.

- History of frequent headaches or migraines (>3 per month), or headaches from an
absence of caffeine.

- Caffeine consumption in excess of 3 cups per day.

- Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever)
within 2 weeks of the first administration of study drug/placebo of each period.

- History of recurrent or chronic infections of any type such as tuberculosis,
sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection,
etc. Also excluded are subjects with recurrent oral or genital herpes, recurrent
herpes zoster, or any infection otherwise judged by the investigator to have the
potential for worsening if enrolled in this study.

- Treatment with LPS in the past 12 months and/or a history of an allergic type reaction
or known hypersensitivity to endotoxin at any time.

NCT01965600
Pfizer
Terminated
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model

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