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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00829088

Enrollment

Registered

2009-01-26

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2009-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Mass balance, AZD2066, Pain, Pain conditions

Brief 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.

Interventions

DRUGAZD2066

1 dose oral solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

35 Years to 50 Years

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

* 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).

Design outcomes

Primary

Measure	Time frame
Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066	Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma	Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.
Metabolite profile in plasma and excreta	Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.

Secondary

Measure	Time frame
AZD2066 metabolites in plasma+excreta if feasable	Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events	Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026