NCT04451811已完成1 期
A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC of OPL-002
研究概览
简要总结
This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Male or female (of non-childbearing potential only) between 18 and 55 years of age.
- •Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
- •hysteroscopic sterilization;
- •bilateral tubal ligation or bilateral salpingectomy;
- •hysterectomy;
- •bilateral oophorectomy, or;
- •be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.
- •Male subjects must use reliable forms of contraception from screening to 30 days after the end of dosing.
- •Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.
排除标准
- •History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- •pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 60-100 beats/min.
- •12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 110 milliseconds (msec), QT/QTcF interval of > 450 msec for men or >470 msec for women, or PR > 200 msec.
- •Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.
研究组 & 干预措施
OPL-002 SDD 20 mg
Experimental
20 mg SDD formulation of OPL-002
干预措施: OPL-002 (Drug)
OPL-002 5 mg Tablet
Experimental
5 mg tablet formulation of OPL-002
干预措施: OPL-002 (Drug)
OPL-002 20 mg Tablet
Experimental
20 mg tablet formulation of OPL-002
干预措施: OPL-002 (Drug)
结局指标
主要结局
AUC of OPL-002
时间窗: 0 to 48 hours
次要结局
- Dose proportionality of 5 and 20 mg(0 to 48 hours)
- Absolute lymphocyte count(0 to 48 hours)
研究者
研究点 (1)
Loading locations...
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