Rheumatoid Arthritis
Conditions
Keywords
AZD5672, relative bioavailability, rheumatoid arthritis (RA)
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
Interventions
DRUGAZD5672
40 mg tablet (Test formulation)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed