NCT02434861已完成1 期
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (1.8 mg/mL Rolapitant IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) 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
- 发起方
- Tesaro, Inc.
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- AUC: area under the plasma concentration-time curve
研究概览
简要总结
The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.
详细描述
- Part A will compare the PK of oral digoxin alone and in combination with an IV infusion of rolapitant.
- Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral dose of sulfasalazine in combination with an IV infusion of rolapitant
- Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in combination with an IV infusion of rolapitant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy males or females aged 18 to 55 years (inclusive)
- •Female subjects (of childbearing potential) must have a negative pregnancy test at Screening and on Day -1
- •Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) before Visit 1 and to continue its use during the study and for at least 30 days after the final dose
- •Subjects must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥50 kg at Screening
- •Subjects must be capable of understanding the informed consent after the risks and benefits of the study have been explained; subjects must be able to sign a written informed consent and be willing to comply with the protocol requirements
- •Subjects must be in general good health as determined by the Investigator based on pre-study medical and surgical history, physical examination [PE], and clinical laboratory tests
排除标准
- •Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of the first study dose
- •Subjects who have a history of relevant allergies (including asthma, food, or drug allergies) as determined by the Investigator
- •Subjects who have had significant blood loss, or have donated or received ≥1 units (450 mL) of blood, within 30 days before the first study dose
- •Subjects who have a history of hypersensitivity to rolapitant IV or any of its excipients or who have participated in a previous rolapitant study within 6 months prior to administration of the first dose of study drug (Day 1)
- •Subjects with poor venous access and/or cannot tolerate venipuncture
- •Subjects with a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject
- •Subjects who have a history of hypersensitivity to sulfasalazine (Part B only).
研究组 & 干预措施
Part A
Experimental
Rolapitant IV and Digoxin
干预措施: Rolapitant (Drug)
Part A
Experimental
Rolapitant IV and Digoxin
干预措施: Digoxin (Drug)
Part B
Experimental
Rolapitant IV and Sulfasalazine
干预措施: Rolapitant (Drug)
Part B
Experimental
Rolapitant IV and Sulfasalazine
干预措施: Sulfasalazine (Drug)
Part C
Experimental
Rolapitant IV and Cooperstown Cocktail
干预措施: Rolapitant (Drug)
Part C
Experimental
Rolapitant IV and Cooperstown Cocktail
干预措施: Cooperstown Cocktail (Drug)
结局指标
主要结局
AUC: area under the plasma concentration-time curve
时间窗: Predose - up to 120 hours postdose
To evaluate the effect of Rolapitant on the PK of probe substrates
Cmax = observed maximum plasma concentration
时间窗: Predose - up to 120 hours postdose
To evaluate the effect of Rolapitant on the PK of probe substrates
次要结局
- Number of participants with adverse events(0 - 38 days)
研究者
研究点 (1)
Loading locations...
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