A Multi-Center, Non-Randomized Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood of Women With a Singleton Pregnancy and a Previous Singleton Spontaneous Preterm Delivery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Plasma concentrations of hydroxyprogesterone caproate and metabolites
研究概览
简要总结
This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy
There will be 3 cohorts of subjects
Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dose of Makena and will have blood drawn immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32 - 36 weeks)
Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have daily blood draws for one week following a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2 successive doses during Epoch 2 (32 - 36 weeks)
Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have blood drawn immediately prior to 2 successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a dose of Makena given during Epoch 2 (32 - 36 weeks)
A maximum of 10 subjects will be monitored on selected days following a completed course of Makena therapy to determine the terminal elimination phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Singleton gestation.
- •Gestational age 16 weeks 0 days to 20 weeks 6 days.
- •Previous singleton spontaneous preterm delivery
排除标准
- •Multifetal gestation.
- •Known major fetal anomaly or fetal demise.
- •Progestin treatment in any form in the 4 weeks prior to study entry.
- •Heparin therapy during current pregnancy or history of thromboembolic disease.
- •Maternal medical/obstetrical complications including hypertension requiring medication or seizure disorder.
- •uterine anomaly other than fibroids
- •Known hypersensitivity to hydroxyprogesterone caproate injection or its components.
- •Any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug or would preclude accurate evaluation of the subject's condition or outcome or compromise the subject's safety in the study.
研究组 & 干预措施
Cohort 1
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation following first dose
干预措施: Hydroxyprogesterone caproate 250 mg/ml (Drug)
Cohort 2
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 24 - 28 weeks gestation
干预措施: Hydroxyprogesterone caproate 250 mg/ml (Drug)
Cohort 3
Hydroxyprogesterone caproate 250 mg/ml. Detailed pharmacokinetic evaluation 32 - 36 weeks gestation
干预措施: Hydroxyprogesterone caproate 250 mg/ml (Drug)
结局指标
主要结局
Plasma concentrations of hydroxyprogesterone caproate and metabolites
时间窗: First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation
次要结局
- Plasma concentrations of hydroxyprogesterone caproate and metabolites(Up to 28 days following last dose given in week 36)