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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
30
Twice daily for 7 days
Twice daily for 7 days
Unnamed facility
London, UK, United Kingdom
Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo
Time frame: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment.
Circulating neutrophils during exercise challenge measured by average neutrophil values over time
Time frame: Pre-dose, 10 min, 2h, 4 hours post exercise test
Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)
Time frame: Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF
Adverse events
Time frame: Screening to Day 63
Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing
Time frame: Pre-dose on Days 1 - 4 On Day 3 with sampling pre-dose and at 1h, 2h, 3h, 5h, 8h, and 12 hours post dose
Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration
Time frame: Pre-dose and 1, 2, 3, 5, 8, 12 hours post each dose on Days 1 - 4, Day 6 and Day 7
Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs, and physical examination findings will be presented
Time frame: Screening to Day 63
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