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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
(Drug Shipment Address ONLY) Duke University Health Systems (DUHS) Investigational Drug Services
Durham, North Carolina, 27710 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01965600
Pfizer
Terminated
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model

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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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
    Other Name: Endotoxin
  • 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
  • Experimental: Cohort 1
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
    • Other: LPS
  • Experimental: Cohort 2
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
    • Other: LPS
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
February 2015
February 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01965600
B5211007
2013-001528-20 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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