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Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704

NCT ID: NCT00692042

Last Updated: 2008-06-24

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

Brief Summary

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The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.

Detailed Description

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Conditions

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Pain

Keywords

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Safety tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD1704

Intervention Type DRUG

One dose, by mouth

Interventions

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AZD1704

One dose, by mouth

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers, man or woman of non child-bearing potential
* Provision of signed informed consent.

Exclusion Criteria

* History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition
* History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje, Sweden

Principal Investigators

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Billy Fahy, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca R&D CPU Nottingham, UK

Lars Ståhle, MD

Role: STUDY_CHAIR

AstraZeneca R&D Södertälje, Sweden

Locations

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Reserach Site

Macclesfield, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D0980C00001

Identifier Type: -

Identifier Source: org_study_id