NCT02960945已完成1 期
An Open-Label Single-Dose Crossover Pharmacokinetic Study to Compare CTP-543 to Jakafi® in Healthy Volunteers
Concert Pharmaceuticals0 个研究点目标入组 12 人开始时间: 2016年11月最近更新:
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
- 12
- 主要终点
- Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions
研究概览
简要总结
This study will assess the metabolite and pharmacokinetic (PK) profile of a single dose of CTP-543 compared to a single dose of Jakafi® in healthy volunteers.
详细描述
The crossover design will assess the safety, tolerability, PK and metabolite profiles of a single dose of CTP-543 compared to a single dose of Jakafi. Approximately 12 healthy volunteers will be enrolled in this open label study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and females between 18 and 50 years of age, inclusive
- •Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive
排除标准
- •History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
- •PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
- •History of herpes zoster
- •Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
- •Liver function tests greater than the upper limit of normal
- •Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
- •Urinalysis positive for protein or glucose
- •A positive screen for alcohol, drugs of abuse, or tobacco use
- •Donation of blood, plasma or other blood products prior to screening
- •A positive tuberculosis test
研究组 & 干预措施
CTP-543
Experimental
Tablet, single oral dose
干预措施: CTP-543, 16 mg (2 x 8 mg tablet) (Drug)
Jakafi
Active Comparator
Tablet, single oral dose
干预措施: Jakafi 15Mg Tablet (Drug)
结局指标
主要结局
Measurement of CTP-543 metabolites and exposure in plasma under fasted conditions
时间窗: 24 hours
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(24 hours)
- Measurement of CTP-543 metabolites and exposure in urine under fasted conditions(24 hours)
研究者
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