Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Phase 1
Completed
- Conditions
- Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug InteractionLaymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction
- Interventions
- Registration Number
- NCT01276262
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 22
Inclusion Criteria
- Female subjects of age 18 to 45 years, inclusive, who are healthy, non-pregnant, not planning pregnancy within the study period
- Willing to use a highly effective method of birth control, ie, double barrier method contraception (condom and diaphragm with spermicide) from the first day of Period 1 until 28 days after the last dose
- Body weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Two negative pregnancy tests at least 7 days apart
Exclusion Criteria
- History of any clinically significant disease or disorder
- History or presence of Gastrointestinal, hepatic, or renal disease
- Any condition listed as a contraindication in the Microgynon® 30 labelling
- Absolute neutrophil count less than 2.5 x 109/L.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Microgynon® 30 (Oral contraceptive) Monophasic oral contraceptive (Microgynon® 30) with placebo tablets Treatment A Placebo Monophasic oral contraceptive (Microgynon® 30) with placebo tablets Treatment B Microgynon® 30 (Oral contraceptive) Monophasic oral contraceptive (Microgynon® 30) and fostamatinib Treatment B fostamatinib Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
- Primary Outcome Measures
Name Time Method 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 From predose until Day 22 of each Treatment period
- Secondary Outcome Measures
Name Time Method To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib From predose until Day 22 of each Treatment period PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin
To determine R-406 plasma concentration-time profile and resulting PK parameters including AUCss, Cssmax, and tmaxss From pre-dose until 12 hours following final dose on Day 21 To determine the safety and tolerability of fostamatinib in combination with an oral contraceptive (Microgynon ®30): adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs Screening, treatment periods 1 and 2, Follow up
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom