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CompletedNCT00829088Updated Feb 25, 2009

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

A Phase 1 interventional study of AZD2066 in Pain, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to male participants aged 35 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-25.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
35 Years to 50 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Pain

Keywords

  • Mass balance
  • AZD2066
  • Pain
  • Pain conditions
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

  • DrugAZD2066

    1 dose oral solution

06

What researchers measure

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.

07

Study locations

1 site
  • Research Site
    Cheshire, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829088
Lead sponsor
AstraZeneca
First posted
Jan 26, 2009
Start date
Jan 2009
Completion
Feb 2009
Last update
Feb 25, 2009

Study contacts

Emeline Ramos, MD
principal investigator · AstraZeneca R&D, CPU Alderley Park, UK
Lars Ståhle, MD
study chair · AstraZeneca R&D, Södertälje, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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