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

June 29, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables
Time Frame: During the dosing visits
During the dosing visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Kyoko Matsuguma, MD, Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D3191C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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