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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014