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

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217645
• Other study ID #: D6702C00030
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2010
• Last updated: October 10, 2014
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Radiation:
• 150 mg [14C] AZD6765

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

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

External Links

•   D6702C00030 Clinical Study Report Synopsis