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This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3043 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3043 | Drug | Intravenous, single dose |
| |
| AZD3043 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B). | From screening period to follow-up visit 42 days (Maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK | Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) | |
| To evaluate the onset, level and recovery of/from sedation/anaesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Ulrike Lorch, MFPM FRCA | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| C573579 | AZD-3043 |
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| Drug |
Infusion, single dose |
|
| Assessed on Day 1 |