AZD5069 Neutrophil Function Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-07-31

Brief Summary

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Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and function (phagocytosis and oxidative burst) in the circulation, following a burst of strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)

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Detailed Description

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A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation after Exercise and Subcutaneous

Conditions

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Chemokine Receptor 2 (CXCR2) Antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD5069 100 mg capsules (50 mg BD) for 7 days

Group Type EXPERIMENTAL

100 mg (50 mg x 2) AZD5069

Intervention Type DRUG

Twice daily for 7 days

2

Placebo twice daily for 7 days

Group Type EXPERIMENTAL

100 mg Placebo

Intervention Type DRUG

Twice daily for 7 days

Interventions

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100 mg (50 mg x 2) AZD5069

Twice daily for 7 days

Intervention Type DRUG

100 mg Placebo

Twice daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening
* Only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal
* Non-smokers or ex-smokers with no smoking history the last 12 months prior to Visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening
* Body mass index (BMI) \>18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg

Exclusion Criteria

* Subjects with a history of or active or latent tuberculosis (TB), or close contact with anybody with active TB
* Subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin)
* Subjects who are pyrexial with a body temperature of greater than 37.7 C at Visit 2, or as judged by the Investigator
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≥1.5 x upper limit of normal (ULN) at screening (Visit 2)
* Peripheral blood neutrophils above or below the laboratory reference range at screening (Visit 2) hsCRP above the upper limit of the laboratory reference range at Visit 2

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes