EUCTR2012-005627-32-GB进行中（未招募）1 期
A randomised, double blind, placebo controlled crossover study of the influence of the HCN channel blocker ivabradine in a healthy volunteer pain model - an enriched population study - The influence of ivabradine in a healthy volunteer pain model
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 24 人开始时间: 2014年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Volunteers who have given written informed consent to participate
- •- Volunteers who can communicate fluently in English
- •- Male or female
- •- Aged 18-64 years
- •- Absence of any chronic pain medicine
- •- Volunteers in good general health, including a body mass index (BMI) in the range of 19-35
- •- Volunteers with a normal resting 12-lead standard ECG including (measured for 1 minute on lead D2): normal sinus rhythm; 60 bpm = HR on resting ECG; PR interval = 210ms; QTcB = 430ms for men and = 450ms for women; QRS duration = 120ms; the results of ECG recordings will be included in the CRF
- •- Women of child bearing potential must use hormonal based contraception for the duration of the trial and 1 week following the end of their trial participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Volunteers with 1 arm
- •- Pre-existing pain on either forearm
- •- Previous surgery or tattoo on either forearm
- •- History of disease associated with neuropathy
- •- Volunteers who are allergic to ivabradine or capsaicin
- •- History of personal or familial Long QT Syndrome
- •- History of cardiac dysrhythmia
- •- Use of CYP3A4 inhibitors such as ketoconazole, itraconazole, macrolide antibiotics and the anti-retrovirals nelfinavir, nefazodone and ritonavir.
- •- Use of CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin or St John’s Wort etc.)
- •- Use of QT interval prolonging medicinal products (e.g. quinidine, disopyramide or pimozide etc.)
- •- Volunteers with any rash or broken skin on the arm where the capsaicin will be applied
- •- Volunteers with lactose intolerance, as the placebo and ivabradine tablets contain lactose
- •- Volunteers with a resting heart rate of 59 beats per minute or less at screening
- •- Volunteers who are pregnant or breast feeding
- •- Female volunteers of childbearing potential who refuse to use hormonal contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- •- Male volunteers who refuse to use adequate contraceptive measures for the duration of the trial as listed in section 11.5 of the protocol
- •- Volunteers who have an underlying medical condition such as migraine or epilepsy which may affect the trial findings
- •- Volunteers who smoke (=5 cigarettes/day), take recreational drugs or consume more than the recommended allowance of alcohol units per week (21 units per week for males and 14 units per week for females)
- •- Participants who are not willing to abstain from drinking beverages containing quinine, caffeine and/or xanthine for 24 hours prior to the trial visit
- •- Volunteers who produce a positive result in a urine screen for drugs of abuse or who are known or suspected to be drug-dependent (sedatives, hypnotics, tranquilizers or any other addictive agent)
- •- Volunteers who produce a positive result in an alcohol breath test
- •- Volunteers currently participating in any interventional trial, have participated in an interventional trial within 16 weeks of screening or are currently participating in a non-interventional trial which participating in this trial would impact upon
- •- Volunteers who, in the opinion of the PI, have a clinically relevant abnormality or medical history that is deemed to make the participant ineligible because of a safety concern.
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