JPRN-jRCT2071230093招募中1 期
Mass Balance Study of KP-001 in Healthy Adult Males (Phase I)
Hanada Ryuzo0 个研究点目标入组 6 人开始时间: 2023年11月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- >= 18age old 至 < 55age old（—）
- 性别
- Male
入选标准
- •1. Japanese males whose age is 18 or over and less than 55 years at the time of consent.
- •2. Weight at screening is 50.0 kg or over.
- •3. BMI at screening is more than 18.0 and less than 25.0
排除标准
- •1. Subjects with central nervous system disease, cardiac disease, circulatory system, respiratory system, blood/hematopoietic system, gastrointestinal system, liver/renal system, thyroid gland function, pituitary gland function, adrenal gland function, or other disorders or pre-existing conditions for which the investigator has determined that conducting the study would raise safety concerns for the subject.
- •2. Subjects with diabetes mellitus (type I or II) or diseases with abnormal glucose metabolism (glycogen storage disease, hypergalactosemia, primary lactose intolerance, etc.) or with a history of such diseases, and for whom the investigator determines that conducting the study would raise safety concerns for the subject.
- •3. Subjects with a history of surgical procedures or medical conditions that the investigator considers having the potential to affect the pharmacokinetics of the investigational drug.
- •4. Subjects who have used or will need to use a drug* within 14 days prior to the administration of the investigational drug.
- •* Includes supplements, vitamins, nutritional drinks and vaccines other than live vaccines. (e.g., influenza vaccine)
- •5. Subjects who have administered or will need to administer the therapy within 14 days prior to the administration of the investigational drug.
- •6. Subjects who received a live vaccine within 90 days prior to administration of the investigational drug.
- •7. Subjects who have consumed citrus fruits (grapefruit, pomelo, dai dai, etc.) or food or beverages containing high levels of furanocoumarins within 72 hours prior to the administration of the investigational drug.
- •8. Subjects who habitually consume excessive amounts of alcohol. (Guideline: average daily consumption of more than 1.3 L of beer or 360 mL of sake)
- •9. Subjects who habitually consume more than 6 cups (1 cup: 150 mL) of coffee, black tea, green tea, cola, or other caffeine-containing food or drink per day
- •10. Subjects who have an excessive smoking habit (Guideline: more than 10 cigarettes per day) or who do not agree with the instructions to stop smoking during the study period.
- •11. Subjects who had a blood collection of 400 mL or more (blood donation, etc.) within 12 weeks (84 days) prior to administration of the investigational drug, a blood collection of 200 mL or more (blood donation, etc.) within 4 weeks (28 days) prior to administration of the investigational drug, or a component blood donation within 2 weeks (14 days), or a total annual blood volume exceeding 1200 mL including planned blood collection for this clinical trial.
- •12. Subjects who received another investigational drug within 16 weeks (112 days) prior to the administration of the investigational drug.
- •13. Subjects with a history of allergy to drugs (including components of the investigational drug) or other special physical condition. (e.g., alcohol hypersensitivity)
- •14. Subjects with drug dependence (narcotics, stimulants, psychotropic drugs, etc.) or alcohol dependence or those with a history of such dependence.
- •15. Subjects who test positive for drugs of abuse in urine at screening.
- •16. Subjects whose 12-lead ECG at screening is judged by the investigator to have a clinically significant ECG abnormality.
- •17. Subjects with positive immunological tests (HBs antigen, HBc antibody, HCV antibody, HIV antigen/antibody and syphilis) at screening.
- •18. Subjects with a positive SARS-CoV-2 test.
- •19. Subjects who have previously participated in a clinical trial of K
研究者
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