NCT01297179已完成1 期
A Double-blind Two-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics (PK) of an Ethinyl Estradiol and Levonorgestrel Containing Combined Oral Contraceptive (COC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples.
研究概览
简要总结
The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects above 35 years inclusive are re-evaluated for the risks of using of a COC
- •Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
- •On oral contraceptive with 30ʯg ethinyl estradiol (EE) plus either 125ʯg or 150ʯg levonorgestrel (LNG) for at least three months prior to date of randomization and well tolerated
- •During the study the subject is willing to use 1 of the 3 following contraceptive methods: diaphragm with spermicide, intrauterine device or partner is using condoms in combination with a spermicidal cream
排除标准
- •Subjects will be excluded from participation if any of the following apply:
- •Known or suspected hypersensitivity to YM178 or any components of the formulation used
- •Pregnant or breast feeding within 6 months before screening assessment
- •Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active Hay-fever)
- •Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
- •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- •Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
- •A marked baseline prolongation of QT/QTc interval after repeated measurements of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
- •Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
- •Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
- •Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
- •History of drinking more than 14 units of alcohol per week (1 unit = 270 cc of beer or 40 cc of spirits or 1 glass of wine) within 3 months prior to admission to the Clinical Unit
- •Positive test for drugs of abuse or positive alcohol test on the day of admission into the clinical unit
- •History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit
- •Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study
- •Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
- •Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
- •Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
- •Unwillingness to use additional barrier contraceptive methods for the course of the study and for one month after the end of study visit
- •Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the study
结局指标
主要结局
Assessment of pharmacokinetics of Ethinyl estradiol (EE) and Levonorgestrel (LNG) by analysis of blood samples.
时间窗: Day 21 + Day 29
次要结局
- Assessment of pharmacokinetics of mirabegron by analysis of blood samples.(Day 21 + Day 49)
研究者
研究点 (1)
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