To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00738322
First received: July 11, 2008
Last updated: June 29, 2009
Last verified: June 2009
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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 May 23, 2013