Major Depressive Disorder
Conditions
Keywords
Major depression disorder
Brief summary
This is a study to assess the distribution, metabolism and excretion of \[14C\]AZD6765 after a single-dose intravenous administration.
Interventions
RADIATION150 mg [14C] AZD6765
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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. | A Range from predose until up to 240 hrs from start of infusion. |
Countries
United Kingdom
Outcome results
None listed