A Double-Blind, Placebo-Controlled, 2-Part, Single Ascending Dose and Multiple Dose Cohort Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events following single doses
研究概览
简要总结
This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in healthy subjects.
详细描述
Single Ascending Dose: Three single ascending dose cohorts are planned. A total of 10 subjects will be enrolled in each cohort and will be randomly assigned to receive a single oral dose of NKT (n=8) or a matching placebo (n=2). A Safety Review Team (SRT) will review all available safety data in a blinded manner following the completion of each cohort to determine the next dose level to be evaluated in the next cohort.
Multiple Dose Cohort: A total of 10 subjects will be enrolled and will be randomly assigned to receive multiple oral doses of NKT (n=8) or a matching placebo (n=2) once daily for an adequate number of days to reach steady state (the number of days will be determined based on the half-life of NKT in Part A). The dose of NKT to be evaluated will be determined by the SRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18 to 30 kg/m^2
- •Negative serum pregnancy test (females); females of childbearing potential and males must agree to use acceptable contraception
排除标准
- •Pregnant or lactating (females)
- •Clinically significant past or current medical or surgical history
- •Clinically significant illness or abnormality on physical examination, 12-lead ECG, laboratory values
- •Participation in an investigational drug or device study within 30 days prior to Screening
研究组 & 干预措施
Norketotifen or Placebo (Multiple Dose)
干预措施: Norketotifen Oral Capsule (Multiple Dose Cohort) (Drug)
Norketotifen or Placebo (Multiple Dose)
干预措施: Placebo Oral Capsule (Drug)
Norketotifen or Placebo (Cohort 1)
干预措施: Norketotifen Oral Capsule (Cohort 1) (Drug)
Norketotifen or Placebo (Cohort 1)
干预措施: Placebo Oral Capsule (Drug)
Norketotifen or Placebo (Cohort 2)
干预措施: Norketotifen Oral Capsule (Cohort 2) (Drug)
Norketotifen or Placebo (Cohort 2)
干预措施: Placebo Oral Capsule (Drug)
Norketotifen or Placebo (Cohort 3)
干预措施: Norketotifen Oral Capsule (Cohort 3) (Drug)
Norketotifen or Placebo (Cohort 3)
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Number of subjects with adverse events following single doses
时间窗: Through Day 4
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
Number of subjects with adverse events following multiple doses
时间窗: Through Day 7
Including clinically significant and Grade 3 abnormalities in laboratory values, vital signs, ECGs, and physical examination
次要结局
- Maximum plasma concentration (Cmax) following single doses(Through Day 4)
- Area under the plasma concentration time curve (AUC) following multiple doses(Through Day 7)
- Apparent clearance (CL/F) following multiple doses(Through Day 7)
- Time to maximum concentration (Tmax) following single doses(Through Day 4)
- Time to maximum concentration (Tmax) following multiple doses(Through Day 7)
- Apparent clearance (CL/F) following single doses(Through Day 4)
- Maximum plasma concentration (Cmax) following multiple doses(Through Day 7)
- Elimination half-life (t1/2) following single doses(Through Day 4)
- Elimination half-life (t1/2) following multiple doses(Through Day 7)
- Apparent volume of distribution (Vz/F) following multiple doses(Through Day 7)
- Area under the plasma concentration time curve (AUC) following single doses(Through Day 4)
- Apparent volume of distribution (Vz/F) following single doses(Through Day 4)