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Completed

NCT Number: NCT01217645

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

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

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

150 mg [14C] AZD6765

Radiation

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: AZD6765

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2010
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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