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AZD5672 Absolute Bioavailability Study

NCT ID: NCT00746837

Last Updated: 2010-12-02

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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AZD5672

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period

2

2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period

AZD5672

Intervention Type DRUG

50 mg od, 12 days

AZD5672

Intervention Type DRUG

150mg od, 12 days

Interventions

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AZD5672

single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period

Intervention Type DRUG

AZD5672

50 mg od, 12 days

Intervention Type DRUG

AZD5672

150mg od, 12 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria

* 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 may influence the results of the study, or the subject's ability to participate
* Unsuitable venous access for intravenous studies
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).
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 R&D Alderely Park

Principal Investigators

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Mark Layton, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Charnwood, UK

Tania Hugo

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Clinical Pharmacology Research Unit

Locations

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Research Site

Harrow, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCt nr 2008-003933-25

Identifier Type: -

Identifier Source: secondary_id

D1710C00018

Identifier Type: -

Identifier Source: org_study_id