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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 November 15, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model
Official Title  ICMJE 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
Brief SummaryAn 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.
Detailed DescriptionThe 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
    • Other: LPS
  • Experimental: Cohort 2
    Interventions:
    • Drug: PF-06282999
    • Drug: Placebo
    • Other: LPS
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 31, 2015)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2013)
36
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion DateFebruary 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01965600
Other Study ID Numbers  ICMJE B5211007
2013-001528-20 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2016

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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