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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014