Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | AZD5069 oral solution |
|
| Placebo | Placebo Comparator | Placebo oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5069 | Drug | Single dose of oral solution. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry. | Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: concentration of AZD5069 in 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 circulating neutrophils | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Sparrow, BSc, BMedSci, BM,BS | AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000597960 | N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Single dose of oral solution. |
|
| Pharmacodynamic profile: 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 48 hours post-dose. |