NCT04843540已完成1 期
A Phase 1 Open-Label Study to Assess the Effect of a Strong CYP3A4 Inducer, Rifampin, on the Single Dose Pharmacokinetic Profile of CTP-543 in Healthy Adult Subjects
Concert Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年5月19日最近更新:
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
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
- •If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days 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, 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 of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- •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 at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •A positive test or history of incompletely treated or untreated tuberculosis
- •Donation of > 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug
研究组 & 干预措施
CTP-543
Experimental
On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of rifampin on Day 4 through Day 15, with a single oral dose of CTP-543 being co-administered on Day 14.
干预措施: CTP-543 (Drug)
结局指标
主要结局
AUC0-t
时间窗: 16 hours
Area Under the Plasma Concentration-Time Profile
AUC0-inf
时间窗: 16 hours
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time
Cmax
时间窗: 16 hours
Maximum observed concentration of drug in plasma
Tmax
时间窗: 16 hours
Time to reach maximum observed concentration of drug in plasma
次要结局
- Number of Participants with Adverse Events (AEs)(Up to 47 days)
研究者
研究点 (1)
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