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

NCT ID: NCT00738322

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 safety pharmacokinetics single ascending doses Japanese male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

Solution for iv infusion, single dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl solution for iv infusion, single dose

Interventions

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AZD1305

Solution for iv infusion, single dose

Intervention Type DRUG

Placebo

NaCl solution for iv infusion, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Kyoko Matsuguma, MD

Role: PRINCIPAL_INVESTIGATOR

Kyushu Clinical Pharmacology Research Clinic, Fukuoka, Japan

Locations

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Research Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D3191C00001

Identifier Type: -

Identifier Source: org_study_id