A Phase I, Open-Label, Fixed-Sequence Study to Determine the Effect of Single and Multiple Oral Doses of CORLUX (TM) (Mifepristone) on the Pharmacokinetics of a Single Oral Dose of Fluvastatin (a CYP2C9 Probe) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the effect of single and multiple oral doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
研究概览
简要总结
This study is to determine the effect of single and multiple oral doses of mifepristone on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
详细描述
This is a fixed-sequence, drug-drug interaction study in healthy volunteers lasting up to a total of 9 weeks: up to 4 weeks screening, approximately 2 weeks for dosing (including a 1-week washout between periods), and approximately 3 weeks of a drug-free interval until termination. The purpose of this study is to determine the effect of single and multiple oral doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy volunteers
- •Body mass index (BMI) of 18-32 kg/m2
- •Female subjects must have a negative serum pregnancy test result prior to entry into the study
- •All female subjects must not be of child-bearing potential
- •All male subjects with female partners of childbearing potential must consent to use a medically acceptable double-barrier method of contraception and not donate sperm throughout the study period and for at least 3 months (90 days) after the last dose of study medication
- •The subject agrees to abstain from grapefruit or grapefruit juice for at least 2 weeks prior to the first dose and until completion of the pharmacokinetic sampling (Day 15)
- •The subject must be able to provide written informed consent
排除标准
- •Any acute or chronic disease state, including but not limited to cardiovascular, dermatological, endocrine, gastrointestinal, hepatic, pulmonary, and renal conditions determined to be clinically significant by the Investigator
- •Any clinically significant abnormal clinical laboratory tests as determined by the Investigator
- •Any concomitant medications (including prescription, over-the-counter or illicit) within either 30 days or five half-lives (whichever is shorter) prior to dosing
- •Positive urine drug screen for any illicit drugs
- •Use of tobacco or any nicotine-containing products during the previous three months
- •Grapefruit juice within two weeks prior to first dose
- •Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
- •Signs and/or symptoms such as orthostatic hypotension, fatigue, anorexia, nausea, abdominal pain, joint and muscle pain if considered to be a marker of adrenal insufficiency
- •History of an allergic reaction to mifepristone or fluvastatin
- •Positive serum test for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus
- •Blood donation within 30 days of dosing
研究组 & 干预措施
1
干预措施: mifepristone + fluvastatin (Drug)
结局指标
主要结局
To determine the effect of single and multiple oral doses of CORLUX on the pharmacokinetics of a single oral dose of fluvastatin administered to healthy volunteers.
时间窗: 8, 9, 12, 13, 14, & 15 days
次要结局
未报告次要终点