NCT01141179已完成1 期
The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- PK parameters
研究概览
简要总结
The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
- •BMI ≥18.0 and ≤ 42 kg/m2
- •Patients with stable concomitant medical conditions
- •Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:
- •≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
- •≥ 30 to < 50 mL/min (Moderate Group: 8 subjects),
- •< 30 mL/min (Severe Group: 8 subjects).
排除标准
- •Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
- •Clinically significant illness or surgery within 4 weeks prior to dosing
- •Clinically significant ECG abnormalities or vital sign abnormalities at screening
- •History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
- •Clinically significant history or presence of any gastrointestinal pathology
- •Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:
- •multivitamins or vitamin D taken on a regular basis
- •topical products without systemic absorption
- •Hemoglobin ≤ 90 g/L
- •Serum total calcium (adjusted for albumin) level < 2.25 mmol/L
- •Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease
研究组 & 干预措施
LEO 27847
Experimental
干预措施: LEO 27847 (Drug)
结局指标
主要结局
PK parameters
时间窗: 1 week
(AUC, Cmax)in each group of renal impairment
次要结局
- PD parameters(1 week)
研究者
研究点 (1)
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