A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females
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
1 other identifier
interventional
26
1 country
1
Brief Summary
A study to compare two different tablet formulations of AZD8931 in healthy males and females.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2011
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJuly 29, 2011
July 1, 2011
1 month
March 22, 2011
July 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period
Secondary Outcomes (1)
To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).
From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.
Study Arms (2)
40 mg AZD8931 wet granulation tablet formulation
ACTIVE COMPARATOR40 mg AZD8931 roller compacted tablet formulation
EXPERIMENTALInterventions
40 mg AZD8931 wet granulation tablet formulation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
MeSH Terms
Interventions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2011
First Posted
April 7, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
July 29, 2011
Record last verified: 2011-07