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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01217645
First received: July 29, 2010
Last updated: October 10, 2014
Last verified: October 2014

July 29, 2010
October 10, 2014
September 2010
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01217645 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Major Depressive Disorder
Radiation: 150 mg [14C] AZD6765
Experimental: 150 mg [14C] AZD6765
Intervention: Radiation: 150 mg [14C] AZD6765
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01217645
D6702C00030
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP