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This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg [14C] AZD6765 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 150 mg [14C] AZD6765 | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765 | Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity | |
| The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765 | Urine and feacal samples will be taken from predose until up to 240 hrs from start of infusion to assess radioactivity |
| Measure | Description | Time Frame |
|---|---|---|
| To identify and profile the metabolites in selected samples of urine, faeces and plasma following a single intravenous dose of 150 mg [14C] AZD6765 | A Range from predose until up to 240 hrs from start of infusion. | |
| Safety and tolerability after a single IV administration of [14C] AZD6765 by assessing a panel of measures: adverse events, blood pressure and pulse, blood samples, urinalysis, hematology, clinical chem, physical exam, ECG and symptoms of suicidality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham, MBBS, DCPSA | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Label | URL |
|---|---|
| D6702C00030 Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
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| A Range from predose until up to 240 hrs from start of infusion. |