A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females

July 28, 2011 updated by: AstraZeneca

A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931

A study to compare two different tablet formulations of AZD8931 in healthy males and females.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects aged 18 to 55 years
  • Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
  • Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
  • Male subjects must be willing to use barrier methods of contraception
  • Be willing and able to comply with study procedures, restrictions and requirements

Exclusion Criteria:

  • History of any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening
  • Use of any prescribed or non-prescribed medication within 2 weeks
  • Receipt of another NCE or participation in any other clinical trial within 3 months
  • Subjects who have previously received AZD8931

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
Active Comparator: 40 mg AZD8931 wet granulation tablet formulation
Drug: AZD8931
40 mg AZD8931 wet granulation tablet formulation
Drug: AZD8931
40 mg AZD8931 roller compacted tablet formulation
Experimental: 40 mg AZD8931 roller compacted tablet formulation
Drug: AZD8931
40 mg AZD8931 wet granulation tablet formulation
Drug: AZD8931
40 mg AZD8931 roller compacted tablet formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.
Time Frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).
Time Frame: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.
From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Mary Stuart, AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK
  • Principal Investigator: Dr Darren Wilbraham, DICP, MBBS, Quintiles Drug Research Unit at Guy's Hospital
  • Study Director: Jason Clark, BSc, Quintiles Drug Research Unit at Guy's Hospital

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

April 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (Estimate)

April 7, 2011

Study Record Updates

Last Update Posted (Estimate)

July 29, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D0102C00005

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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