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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01217645
First received: July 29, 2010
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Radiation: 150 mg [14C] AZD6765
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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 [ Time Frame: Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: A Range from predose until up to 240 hrs from start of infusion. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 150 mg [14C] AZD6765 Radiation: 150 mg [14C] AZD6765

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217645

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01217645     History of Changes
Other Study ID Numbers: D6702C00030
Study First Received: July 29, 2010
Last Updated: February 10, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Major depression disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014