Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314885
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: PF-03715455 Drug: PH-797804 Drug: Placebo for PF-03715455 Drug: Placebo for PH-797804 Phase 1

Detailed Description:
Proof of Mechanism

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: PF-03715455 Drug: PF-03715455
20mg, Inhaled, single dose
Experimental: PH-797804 Drug: PH-797804
30mg, Oral, single dose
Placebo Comparator: Placebo for PF-03715455 Drug: Placebo for PF-03715455
Single dose, inhaled, Placebo for PF-03715455
Placebo Comparator: Placebo for PH-797804 Drug: Placebo for PH-797804
Single Dose, Oral, Placebo for PH-797804

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Number of participants with adverse events [ Time Frame: Baseline, Day 1 and Day 2 ]
  4. Change from baseline in ECG parameters [ Time Frame: Baseline, Day 1 and Day 2 ]
  5. Change from baseline in BP parameters [ Time Frame: Baseline, Day 1 and Day 2 ]
  6. Change from baseline in lab safety parameters [ Time Frame: Baseline, Day 1 and Day 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314885

United Kingdom
Pfizer Investigational Site
London, United Kingdom, SE1 1YR
Pfizer Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01314885     History of Changes
Other Study ID Numbers: A9111003
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases