NCT01635946
已完成
1 期
A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Atorvastatin
概览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) profile for atorvastatin (in plasma):AUCinf, AUClast, Cmax
概览
简要总结
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of atorvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The subject has a body weight of at least 45 kg and a body mass index of 18 to 32 kg/m2, inclusive
- •The subject's clinical laboratory test results at Screening and Day 1 are within normal limits unless the Investigator considers the abnormality to be "not clinically significant." Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin must not be above the normal range
- •Subject agrees to sexual abstinence, or is surgically sterile, or is using a medically acceptable double barrier method to prevent pregnancy during the study and for three weeks after the follow up phone call at the end of the study, or, if female, is postmenopausal
排除标准
- •The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
- •The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission on Day -
- •The subject has received a vaccination within the last 30 days prior to study drug administration
- •The subject has a positive result for hepatitis B surface antigen, hepatitis C antibodies at Screening or is known to be positive for human immunodeficiency virus
- •The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the Investigator), or a history of severe anaphylactic reactions
- •The subject is a smoker (any use of tobacco or nicotine containing products) in the last 6 months
- •The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medication within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
- •The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug screen at Screening or Day -1
研究组 & 干预措施
Isavuconazole and atorvastatin
Experimental
Atorvastatin on Days 1 and 12, Isavuconazole three times per day (TID) on Days 8 and 9, and once daily (QD) on Days 10 thru 15
干预措施: Isavuconazole (Drug)
Isavuconazole and atorvastatin
Experimental
Atorvastatin on Days 1 and 12, Isavuconazole three times per day (TID) on Days 8 and 9, and once daily (QD) on Days 10 thru 15
干预措施: atorvastatin (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profile for atorvastatin (in plasma):AUCinf, AUClast, Cmax
时间窗: Days 1 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to the last quantifiable concentration (AUClast), and maximum concentration(Cmax)
次要结局
- Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs(Day 1 through Day 24 (± 2 days))
- PK Isavuconazole (in plasma): trough concentration (Ctrough)(Predose on Day 10 and Days 13 through 14 and on Day 15 predose and 24 hours post dose)
- PK profile for atorvaststin (in plasma): t1/2, tmax, CL/F, and Vz/F(Days 1 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, and 96 hours postdose)
- PK profile for Isavuconazole (in plasma): AUCtau, Cmax, and tmax(Days 11 and 12 at predose and at 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 20 hours post dose)
研究者
研究点 (1)
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