Status:
COMPLETED
AZD5069 Neutrophil Function Study
Lead Sponsor:
AstraZeneca
Conditions:
Chemokine Receptor 2 (CXCR2) Antagonist
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 fol...
Detailed Description
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 Peripher...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01480739
Start Date
December 1 2011
End Date
July 1 2012
Last Update
June 25 2015
Active Locations (1)
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1
London, UK, United Kingdom