Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
NCT01314885
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 39 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |