AZD5672 Bioavailability Study in Healthy Male and Female Subjects

June 29, 2009 updated by: AstraZeneca

An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
40 or 100mg AZD5672, Reference formulation
Drug: AZD5672
40 mg tablet (Test formulation)
Drug: AZD5672
40 mg tablet (Reference formulation)
Drug: AZD5672
100 mg tablet (Test formulation)
Drug: AZD5672
100 mg (2 x 50 mg tablet (Reference Formulation)
Experimental: 2
40 or 100mg AZD5672, Test formulation
Drug: AZD5672
40 mg tablet (Test formulation)
Drug: AZD5672
40 mg tablet (Reference formulation)
Drug: AZD5672
100 mg tablet (Test formulation)
Drug: AZD5672
100 mg (2 x 50 mg tablet (Reference Formulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Time Frame: Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time Frame: AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Simon Constable, ICON Development Solutions, Manchester, UK
  • Study Chair: Mark Layton, AstraZeneca R&D, Alderley Park, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1710C00019
  • EudraCt No. 2009-009423-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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