Major Depressive Disorder Clinical Trial
— AZD6765Official title:
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
This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | London |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | 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. | No | |
Secondary | 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. | A Range from predose until up to 240 hrs from start of infusion. | Yes |
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