Back to resultsStudy to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration (AZD6765)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
150 mg [14C] AZD6765
Sponsored by
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring Major depression disorder
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
150 mg [14C] AZD6765
Arm Description
Outcomes
Primary Outcome Measures
The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765
Secondary Outcome Measures
To identify and profile the metabolites in selected samples of urine, faeces and plasma following a single intravenous dose of 150 mg [14C] AZD6765
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01217645
Brief Title
Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
Acronym
AZD6765
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a single-dose intravenous administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depression disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
150 mg [14C] AZD6765
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
150 mg [14C] AZD6765
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Wilbraham, MBBS, DCPSA
Organizational Affiliation
Quintiles, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=574&filename=D6702C00030_Clinical_Study_Report_Synopsis.pdf
Description
D6702C00030 Clinical Study Report Synopsis
Learn more about this trial
Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
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