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Completed

NCT Number: NCT00829088

Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed informed consent
  • Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion criteria

  • History of somatic disease/condition, which may interfere with the objectives of the study.
  • History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
  • Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).

Treatment and study plan

AZD2066

Drug

1 dose oral solution

Primary outcomes

  1. Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066

    Time frame: Until >90% of predicted total radioactivity has been recovered

  2. Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma

    Time frame: Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.

  3. Metabolite profile in plasma and excreta

    Time frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.

Secondary outcomes

  1. AZD2066 metabolites in plasma+excreta if feasable

    Time frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.

  2. Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events

    Time frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open Label, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD2066 to Healthy Male Subjects

Important dates

Study start
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Feb 25, 2009

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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