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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

NCT01965600 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-08-02

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

DRUG

PF-06282999

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

DRUG

Placebo

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

OTHER

LPS

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

DRUG

PF-06282999

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

DRUG

Placebo

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

OTHER

LPS

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965600 on ClinicalTrials.gov