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

NCT01217645 | Completed Phase 1

• 1 other identifier: D6702C00030
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

Major depression disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Study Arms (1)

150 mg [14C] AZD6765

EXPERIMENTAL

Radiation: 150 mg [14C] AZD6765

Interventions

150 mg [14C] AZD6765 RADIATION

150 mg [14C] AZD6765

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have a normal creatinine clearance of ≥60 mL/min
• Subjects who self-identify their race as Asian

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Links

• D6702C00030 Clinical Study Report Synopsis

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

AZD6765

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Darren Wilbraham, MBBS, DCPSA

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: October 8, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

GB (1)