AZD5672 Bioavailability Study in Healthy Male and Female Subjects
An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects
2 other identifiers
interventional
24
1 country
1
Brief Summary
The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Mar 2009
Shorter than P25 for phase_1 rheumatoid-arthritis
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
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 30, 2009
June 1, 2009
March 26, 2009
June 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
Secondary Outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period
Study Arms (2)
1
EXPERIMENTAL40 or 100mg AZD5672, Reference formulation
2
EXPERIMENTAL40 or 100mg AZD5672, Test formulation
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study-specific procedures
- BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
You may not qualify if:
- History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Manchester, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mark Layton
AstraZeneca R&D, Alderley Park, UK
- PRINCIPAL INVESTIGATOR
Simon Constable
ICON Development Solutions, Manchester, UK
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2009
First Posted
March 30, 2009
Study Start
March 1, 2009
Study Completion
May 1, 2009
Last Updated
June 30, 2009
Record last verified: 2009-06