NCT02172339已完成1 期
The Pharmacokinetic, Safety and Tolerability of Tiotropium (4.8 mcg, Single i.v. Dose) in Outpatients With Renal Impairment in Comparison to Healthy Subjects (Open Label, Group Comparison, Two-center Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Urinary excretion (0-4h) of tiotropium, Ae 0-4h
研究概览
简要总结
Study to investigate pharmacokinetics of a single i.v. dose of tiotropium (4.8 mcg) in patients with renal impairment in comparison to healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with normal renal function ( creatinine clearance of 80% of predicted creatinine clearance in healthy volunteers), as confirmed by normal physical examination including vital signs, ECG and laboratory values
- •Calculated creatinine clearance (male);
- •= ((140 - age(yr)) x (Wt (kg))) / (72 x predicted serum creatinine (mg/dL))
- •Calculated creatinine clearance (female);
- •= ((140 - age(yr)) x (Wt(kg))) / (85 x predicted serum creatinine (mg/dL))
- •Subject with impaired renal function must be of age related good health and without clinically significant abnormalities as assessed during the physical examination. Mildly impaired renal patients were defined as those with creatinine clearance of 40 - 80% of predicted creatinine clearance; moderately impaired renal patients were defined as those with creatinine clearance of 10 - 40% of predicted creatinine clearance. Laboratory values of subjects with renal impairment could have been outside the normal range if the deviations were due to the underlying renal disease.
- •Male or female, age between 40 and 70 years with normal body - weight index (+/- 25%, Broca-index)
- •Subjects with normal 12 - lead ECG recording
- •Subjects with normal physical examination
- •Subjects with normal clinical and laboratory tests (except for indicators of renal impairment)
- •Female of child bearing potential must have a negative pregnancy test
- •All subjects must have a negative HIV-Ab test and negative Hepatitis B test
- •All subjects must have a negative drug screening
- •All subjects must sign a written informed consent prior to enrollment
排除标准
- •Subjects with a history of more then moderate alcohol consumption (more than 1 litre of beer per day or the equivalent amount of alcohol in any other alcoholic beverage, approximately 50 g of alcohol per day). 24 hours before dosing and 24 hours post dosing, alcohol was not permitted
- •Present or past participation in a drug detoxification program
- •Subjects requiring any concomitant medication not compatible with this study
- •Subjects with hypotension (systolic blood pressure less than 100 mmHg, diastolic less than 60 mmHg) or hypertension (systolic blood pressure more than 165 mmHg or diastolic more than 100 mmHg) under adequate medication
- •Subjects who participated in a clinical trial of any other investigational drug within two months prior to the start of this study
- •Pregnant or lactating women or women of child bearing potential not using a medically approved means contraception. (i.e., oral contraceptives, intrauterine devices, diaphragm)
- •Subjects who donated blood within three months prior to the start of the study
- •Subjects with a history of chronic or recurrent convulsive disorders or ongoing hepatic dysfunction
- •Subjects with ongoing acute systemic illness or recovery from acute systemic illness
- •Subjects with a history of cancer within the last five years
- •Subjects with known hypersensitivity to anticholinergic drugs
- •Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction
- •Subjects with known narrow-angle glaucoma
研究组 & 干预措施
Tiotropium
Experimental
group comparison (healthy, renal impairment)
干预措施: Tiotropium, solution ampoules (Drug)
结局指标
主要结局
Urinary excretion (0-4h) of tiotropium, Ae 0-4h
时间窗: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
Area under the curve (AUC (0-4h) of plasma levels of tiotropium after dosing)
时间窗: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Terminal half-life of tiotropium
时间窗: pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration
Renal clearance of tiotropium (CLren )
时间窗: Day 1, 2, 3, 7, 11, 15, 18, 22 and 25 (0-4h, 4-8h), additionally -4 -0 h on day 1
次要结局
- Maximum measured concentration of the analyte in plasma (Cmax )(pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(pre-dose, 7, 15 , 20, 25, 35, 45 minutes and 1, 2, 4 and 8 hours after drug administration)
- Change in FVC (Forced vital capacity)(baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25)
- Change from baseline in Pulse Rate (PR)(baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25)
- Change from baseline in Blood pressure (BP)(baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25)
- Number of Participants with Serious and Non-Serious Adverse Events(up to day 25)
- Change from baseline in electrocardiogram (ECG)(baseline, day 1, 2, 7, 15 and 25)
- Change in FEV1 (Forced expiratory volume in one second)(baseline, day 1, 2, 3, 7,11, 15,18, 22 and 25)
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