AZD0837 Extended Release (ER) Japan Study

NCT ID: NCT00904800

Last Updated: 2009-07-13

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

2009-05-31

Study Completion Date

2009-06-30

Brief Summary

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This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Low dose

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

tablet, oral, once daily, 1+5 days

2

Middle dose

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

tablet, oral, once daily, 1+5 days

3

High dose

Group Type EXPERIMENTAL

AZD0837

Intervention Type DRUG

tablet, oral, once daily, 1+5 days

4

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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AZD0837

tablet, oral, once daily, 1+5 days

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion Criteria

* Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
* Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
* Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2
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 R&D Molndal

Principal Investigators

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Hiroyuki Fukase, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan

Locations

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Research Site

Kagoshima, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D1250C00055

Identifier Type: -

Identifier Source: org_study_id

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