EUCTR2020-002314-40-AT进行中（未招募）1 期
A Pilot study platform to investigate the pharmacodynamics on QT-prolongation and pharmacokinetics after multiple dose administration of potential combination treatments for COVID-19 in healthy volunteers
Medizinische Universität Wien; Universitätsklinik für Klinische Pharmakologie0 个研究点目标入组 16 人开始时间: 2020年7月15日最近更新:
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
- 16
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
- •Age: between =18 and = 59 years old, has a body weight of at least 50 kg and has a body mass index (BMI) of 18 to 32 kg/m², inclusive
- •Ability to comprehend the full nature and purpose of the study, including possible risks.
- •Physical examination and laboratory analysis: no presence of clinically relevant abnormal findings or values which the investigator considers may interfere with the objectives of the present study.
- •The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and day 1
- •The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age:<18 years old
- •Unwillingness to sign the informed consent
- •The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
- •The subject has a history of pancreatitis
- •The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV) (Virology results not older than 6 months prior to screening are acceptable)
- •The subject has a known or suspected allergy to any of the components of the trial products including ribavirin or lopinavir/ritonavir or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions- - The subject is a smoker (regular use of tobacco or nicotine containing products) within 1 month prior to screening
- •The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day 1, or over-the-counter medications within 1 week prior to Day 1, with the exception of paracetamol up to 1 g/day
- •The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
- •Inability to comprehend the full nature and purpose of the study
研究者
相似试验
尚未招募
4 期
An open-label, pilot study to examine the pharmacokinetics, efficacy and safety of Methylnaltrexone Bromide in paediatric patients with opioid-induced constipation who have failed standard aperient treatment.Opioid-induced ConstipationOral and Gastrointestinal - Normal oral and gastrointestinal development and functionACTRN12611000002987The Royal Children's Hospital6
已完成
不适用
A pilot study to develop a population pharmacokinetic (PopPK) model for vancomycin in underweight subjects with normal renal functioCertain infectious and parasitic diseasesKCT0007923Hanyang University Seoul Hospital12
招募中
Unknown
COVID-19 platform studyCOVID-19C01.748.214JPRN-jRCT1050210015Muto Manabu100
招募中
不适用
Establishment of clinical research platform based on dementia cohortKCT0005516Samsung Medical Center300
已完成
不适用
Pilot study to assess the feasibility and patient numbers required prior to a randomised controlled trial of the effect of visual distraction for painful procedures in the burns unitISRCTN69643568Department of Health10