EUCTR2019-004696-40-FR进行中（未招募）1 期
A phase IV, randomized, double blind cross-over study to evaluate palatability of Patiromer compared to Sodium Polystyrene Sulfonate in healthy subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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 male/female subject, = 25years;
- •2. Body Mass Index (BMI) between 18.5 and 35.0 kg/m2 inclusive;
- •3. Females of childbearing potential/ sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 1 month after the last study drug administration;
- •4. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months);
- •5. Values at sreening for the following tests must be:
- •- Negative blood pregnancy test at screening and D-1;
- •- Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis C (anti HCV), and antibody to human immunodeficiency virus (anti-HIV 1 and 2) at screening and D-1;
- •- Negative drug screen (including alcohol breath test) at screening and D-1;
- •6. Willing to consume standard breakfast and adhere to the study conditions;
- •7. Able to understand the instructions and demonstrate ability to complete study questionnaire;
- •8. Considered as healthy after a comprehensive clinical assessment (detailed medical history, complete physical examination and laboratory evaluation);
- •9. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes in supine position: 95 mmHg = Systolic Blood Pressure (SBP) = 140 mmHg; 50 mmHg = Diastolic Blood Pressure (DBP) = 90 mmHg; 50 bpm = HR = 80 bpm; or considered non clinically significant (NCS) by investigators;
- •10. Normal ECG recording on a 12-lead ECG at the screening visit: 120 < PR < 210 ms, QRS < 120 ms, QTcf = 430 ms for male and < 450 ms for female; No sign of any trouble of sinusal automatism; Or considered NCs by investigators;
- •11. Laboratory parameters within the normal range of the local laboratory (see APPENDIX I). Individual values out of the normal range can be accepted if judged NCS by the Investigator;
- •12. Healthy dental status;
- •13. Regular bowel movements, at least 3 bowel movements weekly without signs of consitipation or diarrhea without using antidiarrheals, prokinetic drugs or enemas in the week before admission;
- •14. Subject has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed including screening procedures;
- •15. Covered by Health Insurance System and/ or in compliance with the recommendations of National Law in force relating to biomedical research.
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •1- A medical history including drugs that could impair their ability to see, smell and taste (see APPENDIX II);
- •2- A clinically significant medical history or laboratory finding not allowing the use of Patiromer and Sodium polystyrene sulfonate, eg hypokalaemia, hyper- and hypocalcaemia, hypomagnesaemia, kidney disease, liver disease, history of obstructive bowel disease, major gastrointestinal surgery;
- •3- Any structural or functional abnormality of the entire gastrointestinal tract incl. constipation or diarrhea and disturbances in swallowing;
- •4- History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/ day);
- •5- Current smoking or smoking within the past 12 months incl. modern e-cigarettes exceeding 5 cigarettes/ day;
- •6- Subject has known sensitivity to any of the Investigational Medicinal Products to be administered;
- •8- Subject has previously entered this study;
- •9- Subject is currently enrolled in or has completed any other investigational device or drug study less than (<)30 days before screening, or is still receiving other investigational agent(s);
- •10- Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding;
- •11- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes of changing from supine to standing position;
- •12- Blood donation (including as part of a clinical trial) within 1 month before administration;
- •13- General anaesthesia within 1 month before administration;
- •14- Presence or history of drug hypersensitivity, especially against Kayexalate® and Veltassa®, or allergic disease diagnosed and treated by a physician;
- •15- Inability to abstain from intense muscular effort;
- •16- No possibility of contact in case of emergency;
- •17- Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
- •18- Positive results of screening for drugs of abuse;
- •19- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- •20- Exclusion period of a previous study;
- •21- Administrative or legal supervision;
- •22- Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study;
- •23- Previous intake of commercially available Kayexalate® and Veltassa®;
- •24- Any employees of Vifor Pharma and Eurofins Optimed incl relatives;
- •25- Use of salt or electrolyte supplements containing sodium, potassium, calcium, phosphate formulations in the week before admission.
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