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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number: 2008-005836-34 |
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The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intravenous solution given as a single ascending bolus dose |
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| 2 | Experimental | Intravenous solution given as a single ascending bolus dose followed by a single infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3043 | Drug | Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B) |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of vital signs data, heart rate, ECG | The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043 | |
| Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea) | The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma. | Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Wemer | AstraZeneca | Study Chair |
| Sigridur Kalman | Karolinska University Hospital | Principal Investigator |
| Stephen Kanes | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26097986 | Derived | Norberg A, Koch P, Kanes SJ, Bjornsson MA, Barassin S, Ahlen K, Kalman S. A Bolus and Bolus Followed by Infusion Study of AZD3043, an Investigational Intravenous Drug for Sedation and Anesthesia: Safety and Pharmacodynamics in Healthy Male and Female Volunteers. Anesth Analg. 2015 Oct;121(4):894-903. doi: 10.1213/ANE.0000000000000804. |
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| ID | Term |
|---|---|
| C573579 | AZD-3043 |
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| PK parameters for the metabolite (THRX 108893): Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, tmax, tlast, lz and t½lz in arterial and venous plasma. |
| Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing |