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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD5069 100 mg capsules (50 mg BD) for 7 days |
|
| 2 | Experimental | Placebo twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg (50 mg x 2) AZD5069 | Drug | Twice daily for 7 days |
| |
| 100 mg Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo | 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 | Pre-dose, 10 min, 2h, 4 hours post exercise test | |
| Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF) | Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Screening to Day 63 | |
| Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Mant, MD | Quintiles research Unit | Principal Investigator |
| Bengt Larsson, MD | AstraZeneca Medical Science Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | UK | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29856004 | Derived | Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| C000597960 | N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide |
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| Drug |
Twice daily for 7 days |
|
| Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration | 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 | Screening to Day 63 |