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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

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NCT01314885

Last updated on March 25, 2020
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Study Location
Pfizer Investigational Site
London, , SE1 1YR United Kingdom
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease (COPD)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female (of non-child bearing potential) subjects, aged 18-50 years.

- Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of
their predicted value for age, race, sex and height.

- Subjects who have normoresponsive airways.

- Subjects who are able to successfully complete screening sputum inductions.

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

- Subjects who have evidence, on review of pre-study laboratory data and full physical
examination, or history of any clinically significant hematological, renal,
endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic
diseases. Specifically liver function tests and CRP must be within the reference
range.

- Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea
at rest).

- Subjects who have experienced a respiratory tract infection within the previous 4
weeks or any other infection within 1 week of dosing

NCT01314885
Pfizer
Completed
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
Official Title  ICMJE Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers
Brief Summary A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.
Detailed Description Proof of Mechanism
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: PF-03715455
    20mg, Inhaled, single dose
  • Drug: PH-797804
    30mg, Oral, single dose
  • Drug: Placebo for PF-03715455
    Single dose, inhaled, Placebo for PF-03715455
  • Drug: Placebo for PH-797804
    Single Dose, Oral, Placebo for PH-797804
Study Arms  ICMJE
  • Experimental: PF-03715455
    Intervention: Drug: PF-03715455
  • Experimental: PH-797804
    Intervention: Drug: PH-797804
  • Placebo Comparator: Placebo for PF-03715455
    Intervention: Drug: Placebo for PF-03715455
  • Placebo Comparator: Placebo for PH-797804
    Intervention: Drug: Placebo for PH-797804
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012) 		39
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2011) 		18
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female (of non-child bearing potential) subjects, aged 18-50 years.
  • Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
  • Subjects who have normoresponsive airways.
  • Subjects who are able to successfully complete screening sputum inductions.

Exclusion Criteria:

  • Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
  • Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
  • Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 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 Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314885
Other Study ID Numbers  ICMJE A9111003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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