A Phase I, Randomized, Open Label, Two-Sequence, Two-Period Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of D-0502 Tablet in Postmenopausal Female Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must be medically documented as healthy and acceptable at physical examination.
- •Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher.
- •Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- •Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- •Subjects must be female with postmenopausal status defined as meeting at least one of the following criteria:
- •Have undergone a bilateral oophorectomy any time in life;
- •Age ≥60 years, or
- •Age <60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]).
- •Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
排除标准
- •Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator.
- •Subjects who have any history or suspicion of kidney stones.
- •Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.
- •Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before Day 1 of study medication dosing.
- •Subjects had undergone major surgery within 3 months prior to Day
- •Subjects who is participating in a clinical research study involving the administration of an investigational or marketed drug or device, or who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
- •Subjects with positive urine drug screen test at screening.
- •Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
研究组 & 干预措施
Sequence AB
D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.
干预措施: D-0502 (Drug)
Sequence BA
D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.
干预措施: D-0502 (Drug)
结局指标
主要结局
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
时间窗: Day 1 through 4, Day 7 through 11
AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM\*hr
Pharmacokinetic: maximum plasma drug concentration (Cmax)
时间窗: Day 1 through 4, Day 7 through 11
Cmax: maximum plasma drug concentration of D-0502; Unit: nM
Pharmacokinetic: Time to reach the Cmax (Tmax)
时间窗: Day 1 through 4, Day 7 through 11
Tmax: Time to reach the Cmax of D-0502; Unit: hr
Pharmacokinetic: Apparent terminal half-life (t1/2)
时间窗: Day 1 through 4, Day 7 through 11
t1/2: apparent terminal half-life of D-0502; Unit: hr
次要结局
- Incidence of Treatment-Emergent Adverse Events(2 weeks)