NCT03927677已完成1 期
A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Colchicine on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Colchicine in Healthy Subjects
LG Chem1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年11月5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
- 24
- 试验地点
- 1
- 主要终点
- Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
研究概览
简要总结
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the PK, PD, safety, and tolerability of LC350189 and colchicine when administered alone and in combination in healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •The subject is male or female 18 to 50 years of age, inclusive.
- •The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
- •The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
- •The subject agrees to comply with all protocol requirements.
- •The subject is able to provide written informed consent.
排除标准
- •The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
- •The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
- •The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
- •The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
- •The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
- •The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
- •The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
- •The subject is a female who is pregnant, planning to become pregnant within the next 6 months, or currently breastfeeding.
- •In the opinion of the investigator, the subject is not suitable for entry into the study.
研究组 & 干预措施
Cohort
Experimental
Period 1: LC350189 200mg Day 1~ Day 4 qd, Period 2: Colchicine 0.6 mg Day 8 ~ Day 15 bid, Period 3 : LC350189 200mg (qd) + Colchicine 0.6 mg (bid) Day 16~ 19
干预措施: Xanthine Oxidase Inhibitor (Drug)
结局指标
主要结局
Maximun observed concentration (Cmax) of LC350189 and Colchicine from plasma
时间窗: from baseline up to Day 21
Pharmacokinetic
Area under the concentration-time curve (AUC) of LC350189 and Colchicine from plasma
时间窗: from baseline up to Day 21
Pharmacokinetic
3.Apparent terminal half-life (t1/2) of LC350189 and Colchicine from plasma
时间窗: from baseline up to Day 21
Pharmacokinetic
次要结局
- Changes in uric serum acid(from baseline up to Day 19)
- Incidence of Adverse events(from baseline up to Day 21)
研究者
研究点 (1)
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