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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06282999; Other: LPS; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965600

B5211007

2013-001528-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Cohort 1

Experimental group

Treatment:

Drug: PF-06282999

Other: LPS

Drug: Placebo

Other: LPS

Drug: Placebo

Drug: PF-06282999

Cohort 2

Experimental group

Treatment:

Drug: PF-06282999

Other: LPS

Drug: Placebo

Other: LPS

Drug: Placebo

Drug: PF-06282999