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Single and Multiple Ascending Doses of AZD1981 in Japan

NCT ID: NCT00698282

Last Updated: 2010-12-01

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

Oral tablet, 250 mg single dose

2

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

Suspension, 15, 75, 1000 and 2000 mg

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD1981

Oral tablet, 250 mg single dose

Intervention Type DRUG

AZD1981

Suspension, 15, 75, 1000 and 2000 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese and Caucasian males

Exclusion Criteria

* Other clinically relevant disease or disorders
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 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 Pharmaceuticals

Principal Investigators

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Elizabeth Hancox

Role: PRINCIPAL_INVESTIGATOR

Europe Chiltern International Ltd, Berkshire, UK

Locations

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Research Site

Berkshire, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D9831C00005

Identifier Type: -

Identifier Source: org_study_id