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Trial record 1 of 1 for:    NCT01314885
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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01314885
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2010
First Posted Date  ICMJE March 15, 2011
Last Update Posted Date February 2, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint [ Time Frame: 6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample. [ Time Frame: 6 hours ]
  • Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample. [ Time Frame: 1, 4, 6 and 7 hours ]
  • Number of participants with adverse events [ Time Frame: Baseline, Day 1 and Day 2 ]
  • Change from baseline in ECG parameters [ Time Frame: Baseline, Day 1 and Day 2 ]
  • Change from baseline in BP parameters [ Time Frame: Baseline, Day 1 and Day 2 ]
  • Change from baseline in lab safety parameters [ Time Frame: Baseline, Day 1 and Day 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
  • Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample. [ Time Frame: 6 hours ]
  • Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample. [ Time Frame: 1, 4, 6 and 7 hours ]
  • Number of participants with adverse events as a measure of safety and tolerability using 12 lead ECG, BP/pulse rate, and laboratory safety tests. [ Time Frame: Baseline, Day 1 and Day 2 ]
  • Measure of phospho p38in sputum. [ Time Frame: 6 hours ]
  • Measure of hsp27 in sputum. [ Time Frame: 6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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