A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
| End Date: | February 2015 |
A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose, 2 Way Crossover Study To Evaluate The Safety And Pharmacodynamic Effects Of Pf 06282999 Using An Endotoxin (Lipopolysaccharide) Induced Inflammatory Response Model In Healthy Adult Subjects
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.
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.
The trial was terminated on 25 March 2015 due to safety concerns regarding the
administration of endotoxin and because of the uncertain availability of future endotoxin
lots.
administration of endotoxin and because of the uncertain availability of future endotoxin
lots.
Inclusion Criteria:
- 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:
- 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.
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