Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00832169

Purpose

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.

Condition	Intervention	Phase
Pain	Drug: AZD1386	Phase I

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers

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+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 [ Time Frame: Until >90% of predicted total radioactivity has been recovered ] [ Designated as safety issue: No ]
Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta [ Time Frame: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AZD1386 metabolites in plasma+excreta if feasable [ Time Frame: Predose, 1h, 4h, 8h 24h ] [ Designated as safety issue: No ]
Safety + tolerability of AZD1386 [ Time Frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental	Drug: AZD1386 1 dose of oral solution

Eligibility

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

Criteria

Inclusion Criteria:

Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
Healthy volunteer must have regular bowel movements (at least once daily)

Exclusion Criteria:

History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832169

Locations

United Kingdom, CHESHIRE
Research Site
MACCLESFIELD, CHESHIRE, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Raj Chetty, 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:	D5090C00015, EudractCT: 2008-006552-22
Study First Received:	January 29, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00832169 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Pain

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on August 28, 2009