EUCTR2017-003440-20-GB进行中（未招募）1 期
A Pharmacokinetic Study of PLENVU® in Healthy Subjects - Pharmacokinetic Study of PLENVU in Healthy Subjects (QCL117983)
orgine Ltd.0 个研究点目标入组 18 人开始时间: 2017年9月8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
- 18
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
- •1.Healthy males or non-pregnant, non-lactating healthy females.
- •2.Age 18 to 30 years
- •3.Body mass index (BMI) of 18.0 to 35.0 kg/m2
- •4.Must be willing and able to communicate and participate in the whole study
- •5.Must provide written informed consent
- •6.Must agree to use an adequate method of contraception
- •Inclusion criteria 4 and 6 from the list above will be re-assessed at admission/pre-dose.
- •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 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Subjects who have received any IMP in a clinical research study within the previous 3 months
- •2.Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •3.Subjects who have previously been enrolled in this study.
- •4.History of any drug or alcohol abuse in the past 2 years
- •5.Regular alcohol consumption in males >21 units per week and females >14 units per week
- •6.Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and at admission
- •7.Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •8.Females who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and admission).
- •9.Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- •10.Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator at screening
- •11.Evidence of dehydration or abnormal electrolyte levels
- •12.History or evidence of any clinically relevant ECG abnormality and hypertension
- •13.Positive drugs of abuse test result
- •14.Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •15.History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or psychiatric disorder, as judged by the investigator
- •16.History or presence of organic or functional gastrointestinal conditions (eg chronic constipation, inflammatory bowel disease or irritable bowel syndrome)
- •17.Previous or current relevant abnormal gastrointestinal motility according to clinical judgement
- •18.History or presence of any clinically significant acute illness within 28 days prior to the first dose of IMP based on clinical judgement at screening or admission
- •19.History of any of the contraindications mentioned in the PLENVU Summary of Product Characteristics
- •20.Clinically relevant findings on physical examination based on investigator judgement
- •21.Donation or loss of greater than 500 mL of blood within the previous 8 weeks
- •22.Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than hormonal contraception and occasional used of non-steroidal anti inflammatory drugs [NSAIDs] and paracetamol) or herbal remedies in the 28 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor’s medical monitor.
- •23.Use of laxatives and gastrointestinal motility altering drug in the last 3 months
- •24. Evidence of current SARS-CoV-2 infection
- •25.Subjects who are ordered to live in an institution on court or authority order
- •26.Failure to satisfy the investigator of fitness to participate for any other reason
研究者
相似试验
已完成
1 期
A Pharmacokinetic Study of PLENVU® in Healthy SubjectsPharmacokineticNCT03437265Norgine19
已完成
不适用
Pharmacokinetics of mixed polyphenol in healthy humansHealthy adultsJPRN-UMIN000033192Kao Corporation20
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-CZMundipharma Research Limited28
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaEUCTR2008-002219-42-ATMundipharma Research Limited28
进行中（未招募）
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-NLMundipharma Research Limited28