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

AstraZeneca1 site in 1 country6 target enrollmentJanuary 2009

ConditionsPain

DrugsAZD2066

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pain
Sponsor: AstraZeneca
Enrollment: 6
Locations: 1
Primary Endpoint: Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

February 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

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.

Metabolite profile in plasma and excreta

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

Secondary Outcomes

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.)