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Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers

NCT ID: NCT00940212

Last Updated: 2010-12-10

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

2009-07-31

Study Completion Date

2009-11-30

Brief Summary

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The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Safety tolerability healthy pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

AZD2423

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

oral, single administration

B

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

oral administration and single dose

Interventions

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AZD2423

oral, single administration

Intervention Type DRUG

Placebo

oral administration and single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
* Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria

* History of 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 results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 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

Principal Investigators

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Rainard Fuhr, MD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Uniit, Berlin Germany

Anders Neijber

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT 2009-010364-42

Identifier Type: -

Identifier Source: secondary_id

D2600C00001

Identifier Type: -

Identifier Source: org_study_id