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A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

NCT ID: NCT00935662

Last Updated: 2010-09-13

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

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Detailed Description

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Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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AZD8329

AZD8329 oral solution

Group Type EXPERIMENTAL

AZD8329

Intervention Type DRUG

Oral solution, single ascending doses

Placebo

Placebo for AZD8329 oral solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution, placebo

Interventions

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AZD8329

Oral solution, single ascending doses

Intervention Type DRUG

Placebo

Oral solution, placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
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 Mölndal, Sweden

Principal Investigators

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Wolfgang Kühn

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB, Phase I Services, Uppsala, Sweden

Locations

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Research Site

Linköping, , Sweden

Site Status

Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT No. 2009-010702-11

Identifier Type: -

Identifier Source: secondary_id

D2350C00001

Identifier Type: -

Identifier Source: org_study_id