Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration

Study Overview
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Brief Summary
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This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.

Official 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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Radiation: 150 mg [14C] AZD6765


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 150 mg [14C] AZD6765<br> | Radiation: 150 mg [14C] AZD6765<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | A Range from predose until up to 240 hrs from start of infusion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression disorder