NCT01167309已完成1 期
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 years (inclusive) at screening.
- •Patients with body mass index within 18 to 34 kg/m2 (inclusive).
- •Haemoglobin is stable (≥9 g/dL or 5.6 mmol/L)
- •Parathyroid hormone (PTH) is ≥200 pg/mL and <800 pg/mL.
- •Screening serum albumin is ≥30 g/L.
- •C-reactive protein <25 mg/L.
排除标准
- •Adjustment of vitamin D sterols within 14 days before the screening visit and patients for whom adjustment of vitamin D sterols is planned from screening until end of study.
- •Adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study.
- •Adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.
研究组 & 干预措施
Part 1 SAD
Active Comparator
four diffferent doses
干预措施: LEO 27847 (Drug)
Part 2a MAD
Placebo Comparator
three doses
干预措施: LEO 27847 (Drug)
Part 2b
Active Comparator
0.24 mg LEO 27847
干预措施: LEO 27847 (Drug)
Part 2c
Active Comparator
0.24 mg LEO 27847
干预措施: LEO 27847 (Drug)
Parat 2a MAD
Placebo Comparator
one dose
干预措施: LEO 27847 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 7 days after last dosing
Adverse events, vital signs, ECG, laboratory evaluation, physical examination
次要结局
- Pharmacokinetics and Pharmacodynamics(7 days after last dosing)
研究者
研究点 (2)
Loading locations...
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