To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00738322

Purpose

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

Condition	Intervention	Phase
Healthy	Drug: AZD1305 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title:	A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	36
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD1305 Solution for iv infusion, single dose
2: Placebo Comparator	Drug: Placebo NaCl solution for iv infusion, single dose

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
Japanese males

Exclusion Criteria:

ECG findings outside normal reference ranges.
Potassium outside normal reference ranges.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738322

Contacts

Contact: Helen Lunde

+46 31 7762475

helen.lunde@astrazeneca.com

Locations

Japan
Research Site	Recruiting
Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Helen Lunde, MD	AstraZeneca R&D Mölndal, Sweden
Principal Investigator:	Kyoko Matsuguma, MD	Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan

More Information

Responsible Party:	AstraZeneca ( Helen Lunde, MD, Medical Science Director, Emerging Arrhythmias & Lipids )
Study ID Numbers:	D3191C00001
Study First Received:	July 11, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00738322
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:

AZD1305
safety
pharmacokinetics

single ascending doses
Japanese
male

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009