EUCTR2016-003073-18-GB进行中（未招募）1 期
A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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
入选标准
- •1.Subject is male
- •2.Subject is 30 to 65 years of age
- •3.Subject has a body weight of at least 50 kg; body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •4.Subject is willing and able to communicate and participate in the whole study
- •5.Subject has regular bowel movements (average stool production =1 and =3 stools per day)
- •6.Subject has suitable veins for multiple cannulation as assessed by the investigator at screening
- •7.Subject is able to comprehend the informed consent form, provide written informed consent, and able to comply with requirements of the study.
- •8.Subject agrees to use an adequate method of contraception
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Subject has received any IMP in a clinical research study within the previous 3 months
- •2.Subject is a study site employee or an immediate family member of a study site or sponsor employee
- •3.Subject has a history of any drug or alcohol abuse in the past 2 years
- •4.Subject has regular alcohol consumption of >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •5.Subject is a current smoker or has smoked within the last 12 months; including cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission
- •6.Subject has radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- •7.Subjects has been enrolled in an ADME study in the last 12 months
- •8.Subject has clinically significant abnormal biochemistry or haematology as judged by the investigator
- •9.Subject has positive drugs of abuse test result
- •10.Subject has positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •11.Subject has evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <90 mL/min using the Cockcroft-Gault equation
- •12.Subject has ALT or AST concentration >1.25 × the upper limit of normal at screening
- •13.Subject has history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
- •14.Subject has had serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •15.Subject has presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- •16.Subject has donated or lost greater than 400 mL of blood within the previous 3 months
- •17.Subject is taking, or has taken, any prescribed or over-the-counter drug (other than 2 g per 24 h paracetamol) dietary or herbal remedies within 14 days before IMP administration, or has taken St. John’s wort within 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.
- •18.Subject fails to satisfy the investigator of fitness to participate for any other reason
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