AZD9056 Relative Bioavailability Study

NCT ID: NCT00908934

Last Updated: 2009-07-23

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

2009-05-31

Study Completion Date

2009-07-31

Brief Summary

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The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

50 or 400 mg AZD9056, Test formulation

Group Type EXPERIMENTAL

AZD9056 formulation Phase III 50 mg (T)

Intervention Type DRUG

Given as 50 mg tablet (T)

AZD9056 formulation Phase III 200 mg (T)

Intervention Type DRUG

Given as 400 mg (2 x 200 mg tablet (T))

2

50 or 400 mg AZD9056, Reference formulation

Group Type EXPERIMENTAL

AZD9056 formulation Phase IIb 50 mg (R)

Intervention Type DRUG

Given as 50 mg tablet (R)

AZD9056 formulation Phase IIb 200mg (R)

Intervention Type DRUG

Given as 400 mg (2 x 200 mg tablet (R))

Interventions

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AZD9056 formulation Phase III 50 mg (T)

Given as 50 mg tablet (T)

Intervention Type DRUG

AZD9056 formulation Phase IIb 50 mg (R)

Given as 50 mg tablet (R)

Intervention Type DRUG

AZD9056 formulation Phase III 200 mg (T)

Given as 400 mg (2 x 200 mg tablet (T))

Intervention Type DRUG

AZD9056 formulation Phase IIb 200mg (R)

Given as 400 mg (2 x 200 mg tablet (R))

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study-specific procedures
* Healthy Volunteers, Females should not be of childbearing potential
* BMI between 18 and 30 kg/m2

Exclusion Criteria

* Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
* A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
* Known or suspected drug or alcohol abuse or positive DOA test
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

Principal Investigators

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Mark Layton

Role: STUDY_DIRECTOR

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 Number: 2009-010554-35

Identifier Type: -

Identifier Source: secondary_id

D1520C00004

Identifier Type: -

Identifier Source: org_study_id

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