Study to Investigate the Effect of a Single Dose of AZD7624 on Inflammation Caused by an Endotoxin Challenge

NCT ID: NCT01937338

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-04-30

Brief Summary

Study to investigate the effect of a single dose of AZD7624 on inflammation caused by an endotoxin challenge.

Detailed Description

This is a double-blind, randomised, placebo controlled, 2-way cross-over study to investigate the effects of a single dose of inhaled AZD7624 on white blood cells and inflammatory markers in induced sputum and blood after oral inhalation of LPS as well as the safety, tolerability and pharmacokinetics (PK) of AZD7624 following a single inhaled dose.

Conditions

LPS Challenge, Neutrophils

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

AZD7624

Group Type: EXPERIMENTAL

AZD7624

Intervention Type: DRUG

nebuliser solution; 20 mg/mL for inhalation

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

nebuliser solution for inhalation

Interventions

AZD7624

nebuliser solution; 20 mg/mL for inhalation

Intervention Type: DRUG

Placebo

nebuliser solution for inhalation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male and/or female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. (Healthy as determined by medical history and physical examination, laboratory parameters, and ECG performed before the first administration of the IP)

2. Female volunteers must have a negative pregnancy test at Visit 1 and on admission (Day -1 of Visit 3 and Visit 5) to the study centre, must not be lactating and must be of non childbearing potential

3. Be able to produce a minimum of 100 mg sputum (pellet weight) of good quality with total cell count (defined as total cell count <14 x 106/g, eosinophils <3%, sputum neutrophil % differential <65%, <30% squamous cell contamination and a minimum of 50% ce

4. Have normoresponsive airways with a methacholine PC20 >16 mg/mL. Screening methacholine provocation is not required if the volunteer has been tested by the centre in the past 1 year, with documented records of this testing

5. Be able to inhale from SPIRA nebuliser

Exclusion Criteria

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate

2. Any infection within the previous 4 weeks. Volunteers who get an infection between Visit 1 and admission to the centre can be rescreened

3. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or reason to expect untoward reactions to LPS and/or AZD7624

4. History of chronic respiratory disease

5. Volunteers who are vegans or have medical dietary restrictions -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saeed Khan, MBBS MRCP

Role: PRINCIPAL_INVESTIGATOR

Quintiles London, UK

Naimish Patel

Role: STUDY_CHAIR

AstraZeneca R&D Boston, United States

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

D2550C00004

Identifier Type: -

Identifier Source: org_study_id