NCT01478568已完成1 期
An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects
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
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegron
研究概览
简要总结
The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.
详细描述
This is an open-label, one-sequence crossover design study to evaluate the drug-drug interaction between mirabegron and desipramine. The effect of mirabegron on the plasma concentration of desipramine will be evaluated after 13 day repeated administration. The recovery of CYP2D6 activity is also being explored by comparing the pharmacokinetic profiles of desipramine after a 2 week wash-out period.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
- •Subject is genotyped and phenotyped as an extensive metabolizer for CYP2D6
排除标准
- •Known or suspected hypersensitivity to YM178 or any of the components of the formulation used
- •Known or suspected hypersensitivity to desipramine or any of the components of the formulation used
- •Pregnant or breast feeding within 6 months before screening assessment
- •Any clinical history of major depressive disorder, cardiovascular disease, urinary retention, glaucoma, thyroid disease and/or seizure disorder
- •Any of the liver function tests (i.e. Alanine Aminotransferase (ALT), Asparate Aminotransferase (AST) and Alkaline phosphatase) above the upper limit of normal at repeated measurements
- •Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- •Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- •Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse rate will be measured automatically)
- •A marked baseline prolongation of QT/QTc interval after repeated measurements of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
研究组 & 干预措施
mirabegron / desipramine
Experimental
干预措施: mirabegron (Drug)
mirabegron / desipramine
Experimental
干预措施: desipramine (Drug)
结局指标
主要结局
Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegron
时间窗: Pre-dose until 72 hours after dosing
次要结局
- Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events(Baseline until End of Study Visit (7 to 14 days after last dose))
- Pharmacokinetics of desipramine assessed by plasma concentration after wash-out of mirabegron(Pre-dose until 72 hours after wash-out)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) StandardSchizophreniaNCT05402111Otsuka Pharmaceutical Development & Commercialization, Inc.31
已完成
1 期
A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922HealthyNCT02661893Janssen Research & Development, LLC14
已完成
3 期
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy SubjectsDepressionNCT00329147Wyeth is now a wholly owned subsidiary of Pfizer20
已完成
4 期
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of MidazolamMajor Depressive DisorderNCT00952653Pfizer28
已完成
1 期
A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy VolunteersHealthy VolunteerNCT01531647Hoffmann-La Roche20