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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the investigational drug on the markers of inflammation. Safety and tolerability will also be assessed.

Key facts

Study ID

NCT01965600

Run by

Pfizer

People needed

23

Starts

2014-03-01

Expected to finish

2015-02-01

Last updated by the study team

2016-08-02

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• (Drug Shipment Address ONLY) Duke University Health Systems (DUHS) Investigational Drug Services — Durham, North Carolina, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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