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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator | Monophasic oral contraceptive (Microgynon® 30) with placebo tablets |
|
| Treatment B | Experimental | Monophasic oral contraceptive (Microgynon® 30) and fostamatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fostamatinib | Drug | Oral tablets, repeated doses for 21 days (2 x 50mg BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To characterise the PD of progesterone, LH, FSH, and SHBG, following dosing with monophasic oral contraceptive (Microgynon® 30) alone and following coadministration with fostamatinib | PD = pharmacodynamics, LH = luteinising hormone, FSH = follicle stimulating, SHBG = Sex hormone binding globulin | From predose until Day 22 of each Treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Microgynon® 30 (Oral contraceptive) |
| Drug |
Oral tablets, repeated doses |
|
| Placebo | Drug | Oral tablets BID, repeated doses for 21 days |
|
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C523665 | fostamatinib |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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