Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314885
• Other study ID #: A9111003
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2010
• Last updated: February 1, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Proof of Mechanism

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PF-03715455
20mg, Inhaled, single dose
• PH-797804
30mg, Oral, single dose
• Placebo for PF-03715455
Single dose, inhaled, Placebo for PF-03715455
• Placebo for PH-797804
Single Dose, Oral, Placebo for PH-797804

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint		6 hours	No
Secondary	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.		6 hours	No
Secondary	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.		1, 4, 6 and 7 hours	No
Secondary	Number of participants with adverse events		Baseline, Day 1 and Day 2	Yes
Secondary	Change from baseline in ECG parameters		Baseline, Day 1 and Day 2	Yes
Secondary	Change from baseline in BP parameters		Baseline, Day 1 and Day 2	Yes
Secondary	Change from baseline in lab safety parameters		Baseline, Day 1 and Day 2	Yes

External Links

•   To obtain contact information for a study center near you, click here.