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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01217645 |
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Date of registration:
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29/07/2010 |
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Primary sponsor: |
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Public title:
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Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
AZD6765 |
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Scientific title:
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A Phase I, Open-label, Single-Centre Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration to Healthy Male Subjects |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01217645 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Darren Wilbraham, MBBS, DCPSA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quintiles |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must have a normal creatinine clearance of =60 mL/min
- Subjects who self-identify their race as Asian
Exclusion Criteria:
- History of any clinically significant medical, neurologic or psychiatric disease as
judged by the investigator
- History of symptomatic orthostatic hypotension (ie, postural syncope)
- Subjects who have received any radiolabelled study drug within 12 months of the
Screening Visit.
- Subjects who are monitored for radioactivity as part of their occupation
- Subjects who have been exposed to radiation levels above background, (eg,
throughX-Ray examinations) of >5mSv in the last year, >10 mSv over the last 5 years
or a cumulative total of >1mSv per year of life.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Intervention(s)
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Radiation: 150 mg [14C] AZD6765
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Primary Outcome(s)
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The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
[Time Frame: Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity]
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The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765
[Time Frame: Urine and feacal samples will be taken from predose until up to 240 hrs from start of infusion to assess radioactivity]
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Secondary Outcome(s)
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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.
[Time Frame: A Range from predose until up to 240 hrs from start of infusion.]
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To identify and profile the metabolites in selected samples of urine, faeces and plasma following a single intravenous dose of 150 mg [14C] AZD6765
[Time Frame: A Range from predose until up to 240 hrs from start of infusion.]
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Secondary ID(s)
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D6702C00030
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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