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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 125 mg, TID, 3 days, 1 of 2 periods

Placebo

Intervention Type DRUG

Tablet, 0 mg, TID, 3 days, 1 of 2 periods

LPS

Intervention Type OTHER

IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Cohort 2

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Tablet, 500 mg, BID, 3 days, 1 of 2 periods

Placebo

Intervention Type DRUG

Tablet, 0 mg, BID, 3 days, 1 of 2 periods

LPS

Intervention Type OTHER

IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Interventions

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PF-06282999

Tablet, 125 mg, TID, 3 days, 1 of 2 periods

Intervention Type DRUG

Placebo

Tablet, 0 mg, TID, 3 days, 1 of 2 periods

Intervention Type DRUG

LPS

IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Intervention Type OTHER

PF-06282999

Tablet, 500 mg, BID, 3 days, 1 of 2 periods

Intervention Type DRUG

Placebo

Tablet, 0 mg, BID, 3 days, 1 of 2 periods

Intervention Type DRUG

LPS

IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Intervention Type OTHER

Other Intervention Names

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Endotoxin Endotoxin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes