An Evaluation of the Pharmacokinetics and Pharmacodynamics of Oral Parathyroid Hormone [PTH (1-34)] and NATPARA® in Patients With Hypoparathyroidism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma PTH(1-34) levels
研究概览
简要总结
A Randomized, active comparator, two-part, partial crossover design. The study is designed to assess the pharmacokinetics and pharmacodynamics of EnteraBio's Oral PTH(1-34) [EB612 (EBP05)] in adult patients with hypoparathyroidism.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Intervention: EB612 (EBP05) 2.25 mg orally (PO) four times a day (QID) (approximately 5 hours apart) for 4 doses, for a total dose of 9 mg per day
干预措施: EB612 (EBP05) (Drug)
Treatment B
Intervention: EB612 (EBP05) 2.25 mg PO twice a day (BID) (approximately 10 hours apart) for 2 doses, for a total dose of 4.5 mg per day
干预措施: EB612 (EBP05) (Drug)
Treatment C
Intervention: NATPARA/NATPAR PTH(1-84) 100 μg subcutaneous injection once daily (single dose)
干预措施: NATPARA/NATPAR (Drug)
Treatment D
Intervention: EB612 (EBP05) 2.25 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 6.75 mg per day
干预措施: EB612 (EBP05) (Drug)
Treatment E - EB612 (EBP05)
Intervention: EB612 (EBP05) 0.75 mg PO TID (dose 1 and dose 2 approximately 10 hours apart; dose 2 and dose 3 approximately 5 hours apart- TID schedule option 2), for a total dose of 2.25 mg per day
干预措施: EB612 (EBP05) (Drug)
结局指标
主要结局
Plasma PTH(1-34) levels
时间窗: 18 weeks
Pharmacokinetic Parameter
Serum albumin-adjusted total calcium levels
时间窗: 18 weeks
Pharmacodynamic Parameter
urinary calcium levels
时间窗: 18 weeks
Pharmacodynamic Parameter
次要结局
- Adverse Events(60 days)
- Rate of Adverse Events leading to discontinuation(60 days)