A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Oral Dosing with AZD8309 on Airway Inflammation as Assessed in Induced Sputum after Challenge with Inhaled Lipopolysaccharide (LPS). - N/A
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- EUCTR2005-002584-90-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1.Provision of informed consent
2.Able to comply with study procedures
3.Healthy male or female of non-child bearing potential (defined as cessation of regular menses for more than 12 months and an FSH of >20 IU/L or surgically sterile)
4.Aged 18-50 years inclusive
5.Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and minimum body weight of 50 kg.
6.Have a normal physical examination, laboratory values, 12-lead ECG and vital signs (blood pressure and pulse), unless the Investigator considers an abnormality to be clinically irrelevant.
7.Be non-smokers, or ex-smokers who have not smoked (or used any other nicotine products) in the 12 months preceding Visit 1 with a pack-year history of less than 10.
8.Be non-atopic as defined by negative skin prick test to common aeroallergens either from a test conducted in the previous 3 years of Visit 1 or at Visit 1 screening.
9.Demonstrate an FEV1 =80% of their predicted normal
10.Demonstrate no evidence of airway obstruction by having and FEV1/FVC ratio > 70%.
11.Have normal airway responsiveness to inhaled methacholine with a PC20=16 mg/ml.
12.Have negative screens for serum Hepatitis B surface antigen, Hepatitis C antibodies and HIV.
13.Be able to produce a minimum of 200 µL sputum volume after induction with inhaled hypertonic saline.
14.Have a sputum eosinophilia < 2% and a sputum neutrophilia < 80%. This sputum neutrophil count is based on the published sputum cell counts in healthy volunteers by Belda et al., 2000. 80% is the mean cell differential plus 2 S.D.s
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs eg, haematological, gastrointestinal, hepatic or renal disease etc.
2.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
3.Previous enrolment or randomisation of treatment in the present study.
4.A definite or suspected personal or family history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the Investigator.
5.Surgery or significant trauma within 3 months of Visit 1.
6.Participation in any clinical study with an investigational drug in the 4 months prior to Visit 1, or participation in a study with a new formulation of a marketed drug in the 3 months prior to Visit 1, or participation in a methodology study in the month prior to Visit 1 (Note: participation is identified as the completion of a treatment –related visit).
7.Donation of more than 1200 mL of blood within 12 months of Visit 1, or donation of blood in total > 500 mL within 3 months prior to Visit 1.
8.Symptoms of any clinically significant illness within 2 weeks prior to Visit 1.
9.Use of any prescribed medication in the 3 weeks prior to Visit 1 (other than hormone replacement therapy (HRT) or over-the-counter preparations (other than paracetamol, maximum 1 g qid) or any herbal preparations and vitamins in the previous 7 days, at the investigators discretion.
10.Subjects who are pyrexial with a body temperature of greater than 37.7oC on days 1 or 3, or as judged by the Investigator.
11.A significant history of alcohol abuse or consumption of more than 28 units (male) or 21 units (female) of alcohol per week.
12.A significant history of drug abuse (including benzodiazepines) or positive drugs of abuse test.
13.Subjects who admit to belonging to a high risk group for HIV infection according to the site’s standard practice.
14.Anticipated difficulty with venous access.
15.Subjects who in the opinion of the Investigator should not, for reasons of the safety or compliance, participate in the study.
16Symptoms, signs or laboratory findings suggestive of an ongoing infective illness as judged by the investigator at the time of enrolment
17A history of respiratory disease including asthma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method