NCT01402076已完成1 期
An Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Tasimelteon on the Cytochrome P450 3A4 and 2C8 Enzymes Using Midazolam and Rosiglitazone as Substrates in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- CYP3A4 Pharmacokinetics
研究概览
简要总结
The purpose of this research study is to understand whether there is any difference in the amount of midazolam (including its breakdown product) in the blood when midazolam is given with tasimelteon, and whether there is any difference in the amount of rosiglitazone in the blood when rosiglitazone is given with tasimelteon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and acceptance to provide written informed consent;
- •Subjects must be males or females between 18 and 55 years of age, inclusive;
- •Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum or urine pregnancy test at the Screening visit and at Check-in (Days -1) and agree not to attempt to become pregnant during the course of the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual bleeding within 1 year) must be using appropriate birth control (e.g. intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or abstinence, or cervical cap) for a period of 35 days before the first dosing, for the duration of the study, and for one month after the last dose;
- •a. Note: Women are not permitted to use hormonal methods of birth control (e.g. oral contraceptives, hormonal intrauterine device [IUD], patch and steroids) and must use another acceptable method of birth control during the study and for one month after the last dose. Women currently taking oral contraceptives will be required to discontinue their regimen two weeks prior to first dosing.
- •Subjects with Body Mass Index (BMI) of >18 and <35 kg/m2 (BMI = weight (kg)/ [height (m)]2);
- •Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
- •Body temperature between 35.0-37.5 °C;
- •Systolic blood pressure between 90-150 mm Hg;
- •Diastolic blood pressure between 50-95 mm Hg;
- •Pulse rate between 50-100 bpm.
- •Willing and able to comply with study requirements;
- •Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis;
排除标准
- •History of recent (within six months) drug or alcohol abuse;
- •Any major surgery within three months of Day 1 or any minor surgery within one month;
- •Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
- •History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- •Any condition requiring the regular use of medication;
- •History of intolerance and/or hypersensitivity to drugs including midazolam, rosiglitazone or other 'glitazones', melatonin or melatonin agonists, or anyone who has taken a melatonin preparation chronically within the past two months prior to Day 1;
- •History of or current evidence of hypoglycemia judged by the Investigator to be clinically significant;
- •History of liver disease and/or positive for one or more of the following serological results: HCV, HIV, HBsAg
- •Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 day preceding Day 1;
- •Elevated (> 2 times the upper limit of normal) liver function tests (i.e. aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and total bilirubin);
- •Inability to be venipunctured and/or tolerate venous access;
- •Subjects who have used tobacco products 3 months prior to dosing.
- •Exposure to any investigational drug within 30 days or 5 half lives (whichever is longer) of baseline, including placebo;
- •Participation in a previous BMS-214778/VEC-162 trial;
- •Use of prescription or OTC medication, including herbal products (e.g., St. John's Wort) within 2 weeks of Day 1;
- •Use of any food or beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g. kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard) and charbroiled meats within 1 week before Day 1 and during the actual duration of the study;
- •Any other sound medical reason as determined by the clinical Investigator.
研究组 & 干预措施
Steady State PK Group
Experimental
干预措施: Tasimelteon (Drug)
Steady State PK Group
Experimental
干预措施: Rosiglitazone (Drug)
Steady State PK Group
Experimental
干预措施: Midazolam (Drug)
No steady state PK
Experimental
干预措施: Tasimelteon (Drug)
No steady state PK
Experimental
干预措施: Rosiglitazone (Drug)
No steady state PK
Experimental
干预措施: Midazolam (Drug)
结局指标
主要结局
CYP3A4 Pharmacokinetics
时间窗: Days 1 and 18
Composite of 24 hour pharmacokinetic parameters of midazolam will be compared between Day 1 and Day 18.
CYP2C8 Pharmacokinetics
时间窗: Days 3 and 20
Composite of 24 hour pharmacokinetic parameters of rosiglitazone will be compared between Day 3 and 20.
次要结局
- Midazolam PK(Days 1 and 17)
- Rosiglitazone PK(Days 3 and 20)
- Tasimelteon multiple dose pharmacokinetics(Days 4-21)
- Tasimelteon safety and tolerability(Days 1-21)
研究者
研究点 (1)
Loading locations...
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