A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy 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 inclusive
- •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.
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
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
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
- •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)
- •Vaccination with a live attenuated vaccine up to 6 weeks prior to dosing. Live vaccines include (but are not limited to) the measles, mumps, and rubella (MMR) vaccine; intranasal flu vaccine; and Zostavax for herpes zoster
研究组 & 干预措施
CTP-543 and Fluconazole Treatment
On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543.
干预措施: CTP-543 (Drug)
CTP-543 and Fluconazole Treatment
On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543.
干预措施: Fluconazole (Drug)
结局指标
主要结局
Tmax
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Time to reach maximum observed concentration
AUC0-inf
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Area under the concentration-time curve from time 0 extrapolated to infinity
t1/2
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Apparent terminal half-life
Cmax
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Maximum observed concentration
λz
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Terminal elimination rate constant
AUC0-tlast
时间窗: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
次要结局
- Assessment of Safety and Tolerability following administration of CTP-543(Continuous from screening (within 21 days prior to Day 1) through Discharge (approximately 7 days after last study drug administration))