To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305 - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00689247

Purpose

The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, disrtibution, metabolism and excretion of AZD1305.

Condition	Intervention	Phase
Healthy	Drug: AZD1305	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Phase I, Open, Randomised, Single-Centre, Crossover Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) After Oral and Intravenous Administration of 14C-Labelled and Non-Labelled AZD1305 to Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetic variables [ Time Frame: During all dosing visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events, vital signs, ECG, laboratory variables and physical examination [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental AZD1305 given as oral solution	Drug: AZD1305 oral solution, single dose
B: Experimental AZD1305 given as iv infusion	Drug: AZD1305 iv infusion, single dose

Eligibility

Ages Eligible for Study:	35 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers
A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

Potassium outside normal reference values
ECG findings outside normal range

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689247

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Helen Lunde, MD	AstraZeneca R&D Mölndal, Sweden
Principal Investigator:	Raj Chetty, MBBS, MD	AstraZeneca CPU Alderley Park, United Kingdom

More Information

Responsible Party:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmia and Lipids )
Study ID Numbers:	D3190C00008, 2007-007784-25 (EudraCT No)
Study First Received:	May 30, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00689247
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

AZD1305
ADME
pharmacokinetic
Absorption

distribution
metabolism
excretion

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009