NCT01657838已完成1 期
A Phase 1, Randomized, Open-Label, Two-Arm, Parallel Group Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult 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
- Pharmacokinetic (PK) profile for isavuconazole (in plasma): AUClast , Cmax
研究概览
简要总结
The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- •Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and total bilirubin must not be above the normal range
- •The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
- •The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period
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 a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
- •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) within 6 months prior to Screening
- •The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of occasionally use of ibuprofen
- •The subject has a recent history (within the last 2 years) of drug or alcohol abuse, or a positive drug and/or alcohol screen
研究组 & 干预措施
Arm 1: isavuconazole only
Experimental
Single dose of isavuconazole on Day 1
干预措施: Isavuconazole (Drug)
Arm 2: isavuconazole + ketoconazole
Experimental
Single dose of isavuconazole on Day 4 and ketoconazole twice daily (BID) for 24 days
干预措施: Isavuconazole (Drug)
Arm 2: isavuconazole + ketoconazole
Experimental
Single dose of isavuconazole on Day 4 and ketoconazole twice daily (BID) for 24 days
干预措施: Ketoconazole (Drug)
结局指标
主要结局
Pharmacokinetic (PK) profile for isavuconazole (in plasma): AUClast , Cmax
时间窗: Day 1 (Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose
Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast) and maximum concentration (Cmax)
次要结局
- PK profile for isavuconazole (in plasma): AUCinf, tmax, CL/F, Vz/F, and t1/2(Day 1(Arm 1) and Day 4 (Arm 2): predose and 0.5, 1, 2, 4, 6, 8, 10, 12, 20, 24, 36, 48, 72, 96,120,144,168,192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480 and 504 hours post-dose)
- PK for ketoconazole (in plasma): trough concentration (Ctrough)(Day 2 (Arm 2): predose)
- PK profile for ketoconazole (in plasma): AUCtau, Cmax, and tmax(Days 3 and 4: predose and 0.5,1, 2, 4, 6, 8,12 and 24 hours post-dose)
- Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs(Day 1 through Day 25 (± 2 days))
研究者
研究点 (1)
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