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

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ClinicalTrials.gov Identifier: NCT01330758
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
A study to compare two different tablet formulations of AZD8931 in healthy males and females.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD8931 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : April 2011
Primary Completion Date : May 2011
Study Completion Date : May 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 40 mg AZD8931 wet granulation tablet formulation Drug: AZD8931
40 mg AZD8931 wet granulation tablet formulation
Experimental: 40 mg AZD8931 roller compacted tablet formulation Drug: AZD8931
40 mg AZD8931 roller compacted tablet formulation


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330758


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
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
More Information

Responsible Party: Mary Stuart/Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01330758     History of Changes
Other Study ID Numbers: D0102C00005
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011

Keywords provided by AstraZeneca:
Phase I
Healthy male and non-fertile female volunteers
Bioavailability
AZD8931