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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treatment A
Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
干预措施: Microgynon® 30 (Oral contraceptive) (Drug)
Treatment A
Monophasic oral contraceptive (Microgynon® 30) with placebo tablets
干预措施: Placebo (Drug)
Treatment B
Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
干预措施: fostamatinib (Drug)
Treatment B
Monophasic oral contraceptive (Microgynon® 30) and fostamatinib
干预措施: Microgynon® 30 (Oral contraceptive) (Drug)
结局指标
主要结局
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
时间窗: From predose until Day 22 of each Treatment period
次要结局
- 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)
- 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)