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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003474-26 |
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This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3043 | Experimental | Intravenous solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3043 | Drug | intravenous solution given once as intravenous infusion over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Vital signs data, heart rate, electrocardiogram (ECG) | The measure will be taken between -20 to 150 min relative to start of administration of AZD3043. | |
| Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea; | The measure will be taken between -20 to 150 min relative to start of administration of AZD3043. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma. | Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose. | |
| PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Wemer | AstraZeneca R&D Södertälje | Study Chair |
| Sigridur Kalman | Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden |
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| ID | Term |
|---|---|
| C573579 | AZD-3043 |
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| 29 min, 45 min and 150 min post dose |