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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: AZD2066

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Cheshire, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Lars Ståhle, MD, AstraZeneca R&D, Södertälje, Sweden; Principal Investigator: Emeline Ramos, MD, AstraZeneca R&D, CPU Alderley Park, UK

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): February 25, 2009
• Last Update Submitted That Met QC Criteria: February 24, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Pain; AZD2066; Mass balance; Pain conditions
• Other Study ID Numbers: D0475C00008; EudractCT No: 2008-006129-14