NL-OMON26870尚未招募不适用
A randomized, single-blinded, 3-way cross-over trial to investigate the pharmacokinetics of sustained release cysteamine bitartrate (PO-001) in healthy adult volunteers.
Patient One0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy male, and 18-55 years of age (inclusive);
- •2. Body Mass Index between 18 and 27 kg/m2 (inclusive) and body weight minimal 50 kg (inclusive);
- •3. Ability to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
- •4. All males must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment;
- •5. Subjects must be able to swallow the drug-administered capsules with the capsule intact;
- •6. Willingness to comply with study restrictions and requirements.
排除标准
- •1. Clinically relevant abnormal history or presence of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit and/or at the start of the first study day (as judged by the investigator);
- •2. Clinically relevant abnormal laboratory results, ECG and vital signs at screening and/or at the start of the first study day (as judged by the investigator);
- •3. Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7 days before the first study day;
- •4. Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2);
- •5. Positive test for hepatitis B, C or HIV at screening;
- •6. History of alcoholism or substance abuse within three years prior to screening or current use of more than 21 units alcohol per week or drug abuse;
- •7. Subjects using, on average, more than 3 units of alcohol per day, and unable to refrain from alcohol use from 24 hours prior to screening, each study day and whilst in study unit;
- •8. Subjects smoking, on average, more than 5 cigarettes per day, and unable to refrain from smoking during the study days;
- •9. Positive drug- (i.e. positive for cocaine, opioids, amphetamines, opiates, cannabinoids, benzodiazepines, and/or methadone) or alcohol test at screening and/or first study day;
- •10. Inability to refrain from the use of concomitant (prescription and over the counter) medication which, in the opinion of the investigator, interferes with their ability to participate in the trial, from one week (or less than 5 half-lives (whichever is longer) prior to the first the first study day until the last study day;
- •11. Use of any dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions can be made as judged by the investigator;
- •12. A history of severe allergies, or has had an anaphylactic reaction or significant intolerability (hypersensitivity) to prescription or non-prescription drugs or food;
- •13. Hypersensitive (allergic) to cysteamine (mercaptamine) or any of the other ingredients, e.g. to penicillamine;
- •14. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug;
- •15. Participation in an investigational drug study within 90 days prior to screening or more than 4 times a year;
- •16. Loss or donation of blood over 500 mL within 90 days prior to screening or intention to donate blood or blood products during the study;
- •17. Inadequate venous accessibility as judged by the physician or nurse;
- •18. Any known factor, condition, or disease or any reason that might interfere in the opinion of the medical responsible person with the well-being of the subject, treatment compliance, study conduct or interpretation of the results.
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