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Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers

NCT ID: NCT00729443

Last Updated: 2008-11-13

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

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The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Single dose Phase 1 Safety of AZD3241 tolerability of AZD3241

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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1

Group Type EXPERIMENTAL

AZD3241

Intervention Type DRUG

single oral dose

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD3241

single oral dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
* Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion Criteria

* Clinically significant illness within the 2 weeks prior to the administration of the investigational product
* Heart rate (resting, recumbent) \<50 bmp or \>85 bmp
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 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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Ingemar Bylesjö

Role: PRINCIPAL_INVESTIGATOR

Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudractCT# 2008-002466-62

Identifier Type: -

Identifier Source: secondary_id

D0490C00012

Identifier Type: -

Identifier Source: org_study_id