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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00738322
First received: July 11, 2008
Last updated: June 29, 2009
Last verified: June 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

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
Study Completion Date: October 2008
Arms Assigned Interventions
Experimental: 1 Drug: AZD1305
Solution for iv infusion, single dose
Placebo Comparator: 2 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

Locations
Japan
Research Site
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

No publications provided

Responsible Party: Helen Lunde, MD, Medical Science Director, Emerging Arrhythmias & Lipids, AstraZeneca
ClinicalTrials.gov Identifier: NCT00738322     History of Changes
Other Study ID Numbers: D3191C00001
Study First Received: July 11, 2008
Last Updated: June 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
AZD1305
safety
pharmacokinetics
single ascending doses
Japanese
male

ClinicalTrials.gov processed this record on April 16, 2014