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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00829088

Purpose

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	Intervention	Phase
Pain	Drug: AZD2066	Phase I

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Urine and Urination

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Metabolite profile in plasma and excreta [ Time Frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AZD2066 metabolites in plasma+excreta if feasable [ Time Frame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]

Enrollment:	6
Study Start Date:	January 2009
Study Completion Date:	February 2009

Intervention Details:

1 dose oral solution

Eligibility

Ages Eligible for Study:	35 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829088

Locations

United Kingdom
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

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Södertälje, Sweden ( Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience )
Study ID Numbers:	D0475C00008, EudractCT No: 2008-006129-14
Study First Received:	January 23, 2009
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00829088 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Mass balance
AZD2066
Pain
Pain conditions

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on September 10, 2009