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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00829088
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: AZD2066	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official 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
• Study Start Date: Jan 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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.]

3. Metabolite profile in plasma and excreta [Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.]

Secondary Outcome Measures

1. AZD2066 metabolites in plasma+excreta if feasable [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 [Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Cheshire		United Kingdom

Sponsors and Collaborators

• AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00829088
• Other Study ID Numbers: D0475C00008; EudractCT No: 2008-006129-14
• First Posted: Jan 26, 2009
• Last Update Posted: Feb 25, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Mass balance; AZD2066; Pain; Pain conditions

Study Results

No Results Posted as of Feb 25, 2009