A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- AUClast (DR single dose cohort)
研究概览
简要总结
A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be willing and able to provide written informed consent.
- •BMI within the range 18 to 25 kg/m2.
排除标准
- •History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
- •Clinically significant lab/ECG abnormalities in the opinion of the investigator.
- •WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.
- •Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.
- •WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
- •WOCBP who are pregnant or breastfeeding.
- •WOCBP with a positive pregnancy test prior to randomization.
- •Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
- •Presence of uncontrolled or severe medical illness.
- •Presence of a disease that require surgery at any time during the study.
研究组 & 干预措施
YH12852 IR 0.5mg
Once daily
干预措施: YH12852 IR 0.5mg (Drug)
YH12852 IR 0.05mg
Once daily
干预措施: YH12852 IR 0.05mg (Drug)
YH12852 IR 0.1mg
Once daily
干预措施: YH12852 IR 0.1mg (Drug)
YH12852 IR 0.3mg
Once daily
干预措施: YH12852 IR 0.3mg (Drug)
YH12852 IR 1mg
Once daily
干预措施: YH12852 IR 1mg (Drug)
YH12852 IR 2mg
Once daily
干预措施: YH12852 IR 2mg (Drug)
YH12852 IR 3mg
Once daily
干预措施: YH12852 IR 3mg (Drug)
YH12852 DR1 0.5mg
Once daily
干预措施: YH12852 DR1 0.5mg (Drug)
YH12852 DR1 1mg
Once daily
干预措施: YH12852 DR1 1mg (Drug)
YH12852 DR1 2mg
Once daily
干预措施: YH12852 DR1 2mg (Drug)
YH12852 DR1 4mg
Once daily
干预措施: YH12852 DR1 4mg (Drug)
YH12852 DR2 8mg
Once daily
干预措施: YH12852 DR2 8mg (Drug)
Prucalopride 2mg
Once daily
干预措施: Prucalopride 2mg (Drug)
Placebo
Once daily
干预措施: Placebo (Drug)
结局指标
主要结局
AUClast (DR single dose cohort)
时间窗: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
C(IR multiple dose cohort)
时间窗: Day 5, 10, 12 and 13
CD5, CD10, CD12, CD13
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
时间窗: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
时间窗: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
时间窗: Day 14
C(DR multiple dose cohort and Multiple low-dose IR cohort)
时间窗: Day 5, 13 and 14
CD5, CD13, CD14
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
时间窗: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Cmax,ss (DR single dose cohort)
时间窗: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
次要结局
未报告次要终点