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The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8566 | Drug | 10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: concentration of AZD8566 in blood | Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10 | |
| Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events | Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile: concentration of AZD8566 in urine | Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emeline Ramos, MD | Clinical Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Macclesfield | Cheshire | United Kingdom |
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| Placebo | Drug | 10ml oral solution administered once a day over 10 days. |
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