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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018185-35 | EudraCT Number |
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This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5069 | Drug | Oral suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry | From screening period to follow-up visit 42 days (Maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose | |
| Measurement of the effect of AZD5069 on blood cells | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Lorch, Lorch, MD MFPM FRCA | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Croydon | 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 |
Oral suspension |
|
| Pharmacokinetic profile: concentration of AZD5069 in blood | Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. |