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AZD5672 Bioavailability Study in Healthy Male and Female Subjects

NCT ID: NCT00871767

Last Updated: 2009-06-30

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-05-31

Brief Summary

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The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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AZD5672 relative bioavailability rheumatoid arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

40 or 100mg AZD5672, Reference formulation

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

40 mg tablet (Reference formulation)

AZD5672

Intervention Type DRUG

100 mg (2 x 50 mg tablet (Reference Formulation)

2

40 or 100mg AZD5672, Test formulation

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

40 mg tablet (Test formulation)

AZD5672

Intervention Type DRUG

100 mg tablet (Test formulation)

Interventions

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AZD5672

40 mg tablet (Test formulation)

Intervention Type DRUG

AZD5672

40 mg tablet (Reference formulation)

Intervention Type DRUG

AZD5672

100 mg tablet (Test formulation)

Intervention Type DRUG

AZD5672

100 mg (2 x 50 mg tablet (Reference Formulation)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study-specific procedures
* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Minimum Eligible Age

18 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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Mark Layton

Role: STUDY_CHAIR

AstraZeneca R&D, Alderley Park, UK

Simon Constable

Role: PRINCIPAL_INVESTIGATOR

ICON Development Solutions, Manchester, UK

Locations

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Research Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCt No. 2009-009423-10

Identifier Type: -

Identifier Source: secondary_id

D1710C00019

Identifier Type: -

Identifier Source: org_study_id