Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects
Overview
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
Full Title of Study: “A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Single (Participant)
- Study Primary Completion Date: November 2011
Interventions
- Drug: fostamatinib
- Oral tablets, repeated doses for 21 days (2 x 50mg BID)
- Drug: Microgynon® 30 (Oral contraceptive)
- Oral tablets, repeated doses
- Drug: Placebo
- Oral tablets BID, repeated doses for 21 days
Arms, Groups and Cohorts
- Placebo Comparator: Treatment A
- Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
- Experimental: Treatment B
- Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib
- Time Frame: 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
- Time Frame: 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
- Time Frame: Screening, treatment periods 1 and 2, Follow up
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- AstraZeneca
- Provider of Information About this Clinical Study
- Sponsor
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