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Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

NCT ID: NCT00687232

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase I Japan Japanese inhalation

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

AZD4818

Group Type EXPERIMENTAL

AZD4818

Intervention Type DRUG

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD4818

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Body Mass Index (BMI) between 18.0-27.0 kg/m2
* No clinically relevant abnormal findings

Exclusion Criteria

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
* Clinical relevant disease or disorder (past or present)
* A history of respiratory 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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Michio Yagi

Role: PRINCIPAL_INVESTIGATOR

Osaka Pharmacology Clinical Research Hospital

Locations

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Research Site

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D3540C00010

Identifier Type: -

Identifier Source: org_study_id