Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
- Sponsor
- AstraZeneca
- Study ID
- NCT01276262
- Phase
- PHASE1
- Status
- Completed
Conditions
- Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction
- Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- fostamatinib — DRUGOral tablets, repeated doses for 21 days (2 x 50mg BID)
- Microgynon® 30 (Oral contraceptive) — DRUGOral tablets, repeated doses
- Placebo — DRUGOral tablets BID, repeated doses for 21 days
Study Details
A crossover study to assess the effect of repeated doses of fostamatinib on the levels of oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib. The study will also evaluate the safety and tolerability of fostamatinib in combination with an oral contraceptive
Key Dates
- Start date
- Mar 31, 2011
- Status verified
- Feb 2012
- Primary completion
- Nov 30, 2011
- Completion
- Nov 30, 2011
Study Design
- Enrollment
- 22 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Placebo Comparator: Treatment AMonophasic oral contraceptive (Microgynon® 30) with placebo tablets
- Experimental: Treatment BMonophasic oral contraceptive (Microgynon® 30) and fostamatinib
Primary Outcome Measure
To assess the effects of repeated doses of Fostamatinib on the pharmacokinetics of Microgynon ®30 by assessment of Cssmax and AUCss of ethinyl estradiol (EE), levonorgestrel on Day 21 [ Time Frame: From predose until Day 22 of each Treatment period ]