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
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 April 17, 2014