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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: LPS Challenge, Neutrophils

Treatments: Drug: AZD7624; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937338

D2550C00004

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

AZD7624

Experimental group

Treatment:

Drug: AZD7624

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo