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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010702-11 | EudraCT Number |
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The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot panel | Experimental | [11C]AZ12807110 distribution and kinetics |
|
| Main panel | Experimental | Histamine receptor occupancy reached by AZD5213 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]AZ12807110 | Other | Radioligand |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution volume (VT) | Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours. | |
| Estimation of the plasma concentration resulting in 50% receptor occupancy (Ki, pl). | Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213. | Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Collected from Day 1 to follow-up | |
| Vital signs (body temperature, BP and pulse) | Measured at screening, study days -1 to day 3 and at follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Paulsson, MD | AstraZeneca | Study Director |
| Wolfgang Kühn, MD | Quintiles AB, Uppsala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23217964 | Derived | Jucaite A, Takano A, Bostrom E, Jostell KG, Stenkrona P, Halldin C, Segerdahl M, Nyberg S. AZD5213: a novel histamine H3 receptor antagonist permitting high daytime and low nocturnal H3 receptor occupancy, a PET study in human subjects. Int J Neuropsychopharmacol. 2013 Jul;16(6):1231-9. doi: 10.1017/S1461145712001411. Epub 2012 Dec 10. |
| Label | URL |
|---|---|
| D3030C00003 Clinical Study Report Synopsis | View source |
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| AZD5213 |
| Drug |
|