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This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C] AZD5069.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | [14C] AZD5069 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] AZD5069 | Drug | Single 120 mg oral dose administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood | To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)). | From pre-dose until 168 hours post last dose |
| To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax). | From pre-dose until 168hours post last dose | |
| To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance. | From pre-dose until 168hours post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of AZD5069 given orally | Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported. | From screening visit, Day 12, up to follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Tim Mant, FRCP, FFPM | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | 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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