To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738322
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : June 30, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD1305 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : July 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD1305
Solution for iv infusion, single dose
Placebo Comparator: 2 Drug: Placebo
NaCl solution for iv infusion, single dose

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic variables [ Time Frame: During the dosing visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00738322

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

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmias & Lipids, AstraZeneca Identifier: NCT00738322     History of Changes
Other Study ID Numbers: D3191C00001
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
single ascending doses