Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

NCT ID: NCT00713271

Last Updated: 2014-04-10

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-11-30

Brief Summary

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The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Low dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

Low dose

Dry powder for inhalation, o.d., 1+12 days

2

intermediate dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

intermediate dose

Dry powder for inhalation, o.d., 1+12 days

3

high dose

Group Type EXPERIMENTAL

AZD3199

Intervention Type DRUG

high dose

Dry powder for inhalation, o.d., 1+12 days

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD3199

Low dose

Dry powder for inhalation, o.d., 1+12 days

Intervention Type DRUG

Placebo

Intervention Type DRUG

AZD3199

intermediate dose

Dry powder for inhalation, o.d., 1+12 days

Intervention Type DRUG

AZD3199

high dose

Dry powder for inhalation, o.d., 1+12 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 19-30, weight 60-100 kg
* Non/ex-smokers, Non/ex-nicotine users

Exclusion Criteria

* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings at screening examinations
* Use of any prescribed or non-prescribed medication
Minimum Eligible Age

18 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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Responsibility Role SPONSOR

Principal Investigators

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Gabriella Samuelsson Palmgren

Role: PRINCIPAL_INVESTIGATOR

AZ CPU Lund, Sweden

Locations

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Research Site

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D0570C00002

Identifier Type: -

Identifier Source: org_study_id

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