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AZD3355 Dose-escalation Study in Healthy Males

NCT ID: NCT00757419

Last Updated: 2010-12-07

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.

Detailed Description

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Conditions

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Reflux Disease

Keywords

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Safety tolerability healthy subjects

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

Group Type EXPERIMENTAL

AZD3355

Intervention Type DRUG

capsules, oral, single or twice daily dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

To match dosing of AZD3355

Interventions

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AZD3355

capsules, oral, single or twice daily dose

Intervention Type DRUG

Placebo

To match dosing of AZD3355

Intervention Type DRUG

Other Intervention Names

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Lesogaberan

Eligibility Criteria

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Inclusion Criteria

* Subjects without concurrent diseases who do not require any medical treatments
* Provision of signed informed consent.

Exclusion Criteria

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
* Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
* History of clinically significant orthostatic reaction or syncope
* Clinically important abnormalities related to the heart function
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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AstraZeneca Pharmaceuticals

Principal Investigators

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Marianne Hartford

Role: PRINCIPAL_INVESTIGATOR

CPU Avd 102, Gröna Stråket 12, Sahlgrenska Universitetssjukhuset, 413 45 Göteborg

Eva Ersdal

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCTnr: 2008-003578-16

Identifier Type: -

Identifier Source: secondary_id

D9120C00030

Identifier Type: -

Identifier Source: org_study_id