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Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

NCT ID: NCT00754715

Last Updated: 2008-12-15

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Detailed Description

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Conditions

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Healthy

Keywords

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Multiple dosing study, safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD2516

Group Type EXPERIMENTAL

AZD2516

Intervention Type DRUG

Solution administered once orally

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution administered only once

Interventions

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AZD2516

Solution administered once orally

Intervention Type DRUG

Placebo

Solution administered only once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
* Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria

* History of previous or ongoing psychiatric disease.
* Abnormalities in ECG that may interfere with interpretation of data.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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 Pharmaceuticals

Principal Investigators

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Bo Fransson, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Lars Ståhle, MD, PhD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudractCT: 2008-003598-42

Identifier Type: -

Identifier Source: secondary_id

D2080C00001

Identifier Type: -

Identifier Source: org_study_id