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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

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NCT01314885

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
London, , SE1 1YR United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
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
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.
Proof of Mechanism
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Chronic Obstructive Pulmonary Disease (COPD)
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01314885
A9111003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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