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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01330758
First received: March 22, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD8931
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mary Stuart/Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01330758     History of Changes
Other Study ID Numbers: D0102C00005
Study First Received: March 22, 2011
Last Updated: July 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 19, 2014