A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female, aged 18-60
- •Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- •If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication
- •Capable of giving informed consent and complying with study procedures
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- •Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
- •History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) > 450 msec for males or QTcF > 470 msec for females at screening visit or prior to the first dosing
- •Abnormal liver function at screening
- •Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
- •Positive results for coronavirus infection (COVID-19) at screening or check-in
- •Positive drug or alcohol results at screening or check-in
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •Participation in another clinical study within 30 days prior to, and 30 days after the first dosing.
研究组 & 干预措施
CTP-543
Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16.
干预措施: Midazolam (Drug)
CTP-543
Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16.
干预措施: CTP-543 (Drug)
结局指标
主要结局
Cmax
时间窗: Day 14, 15, 16, Discharge (Day 17)
Maximum observed concentration
Tmax
时间窗: Day 14, 15, 16, Discharge (Day 17)
Time to reach maximum observed concentration
AUC0-inf
时间窗: Day 14, 15, 16, Discharge (Day 17)
Area under the concentration-time curve from time 0 extrapolated to infinity
AUC0-t
时间窗: Day 14, 15, 16, Discharge (Day 17)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
λz
时间窗: Day 14, 15, 16, Discharge (Day 17)
Terminal elimination rate constant
t1/2
时间窗: Day 14, 15, 16, Discharge (Day 17)
Apparent terminal half-life
CL/F
时间窗: Day 1, 2, 16, Discharge (Day 17)
Apparent total plasma clearance (Midazolam only)
Vz/F
时间窗: Day 1, 2, 16, Discharge (Day 17)
Apparent volume of distribution (Midazolam only)
次要结局
- Assessment of Safety and Tolerability following administration of CTP-543(Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration))