Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01314885
First received: November 5, 2010
Last updated: February 1, 2012
Last verified: February 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: PF-03715455 Drug: PH-797804 Drug: Placebo for PF-03715455 Drug: Placebo for PH-797804 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Number of participants with adverse events [ Time Frame: Baseline, Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
- Change from baseline in ECG parameters [ Time Frame: Baseline, Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
- Change from baseline in BP parameters [ Time Frame: Baseline, Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
- Change from baseline in lab safety parameters [ Time Frame: Baseline, Day 1 and Day 2 ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
Proof of Mechanism
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314885
Locations
| United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 1YR | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M23 9QZ | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01314885 History of Changes |
| Other Study ID Numbers: | A9111003 |
| Study First Received: | November 5, 2010 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Pfizer:
|
Healthy |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013