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

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Radiation: 150 mg [14C] AZD6765

• Registration Number: NCT01217645
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-29
• Study Start: 2010-09
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
150 mg [14C] AZD6765	150 mg [14C] AZD6765	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom