jRCT2071220045已完成不适用
SK-5307 Phase I (single-dose study in healthy adult male subjects)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 45age old not（—）
- 性别
- Male
入选标准
- •Subjects aged 18 years or older but less than 45 years (at the time of informed consent).
- •Subjects with BMI (weight (kg)/[height (m)]2) in the following ranges (at the time of screening).
- •Japanese healthy adult males: 18.5 to less than 25.0
- •Caucasian healthy adult males: 18.0 to less than 30.0
- •Subjects considered eligible for this study based on the results of screening examination by the investigator or sub-investigator.
- •Subjects who have the capacity to consent and whose written consent has been obtained from the subject.
排除标准
- •Subjects with current medical history.
- •Subjects with a history of liver disease, renal disease, cardiovascular disease, hematological disease, endocrine system disease, digestive system disease, respiratory system disease, psychiatric or cranial nerve disease (including epilepsy), infectious disease that the investigator or sub-investigator judges to affect the safety of the subject or the evaluation of the investigational drug.
- •Subjects with clinically abnormalities in the screening or 12-lead electrocardiogram at rest on the day of admission.
- •Subjects with a complication or a history of drug dependence or alcohol dependence.
- •Subjects with a complication or a history of drug hypersensitivity.
- •Subjects with a complication or a history of food allergy.
- •Subjects who had an average of 20 grams or more of alcohol per day.
- •Subjects who used any drug or supplement within 2 weeks prior to hospitalization for this study.
- •Subjects who had food or beverages containing grapefruit (juice or pulp) within 3 days prior to hospitalization for this study.
- •Subjects who had ingested food or beverages containing St. John's wort (St. John's wort) within 1 week prior to hospitalization to the study.
- •Subjects who have donated 400 mL whole blood within 12 weeks prior to hospitalization in this study, 200 mL whole blood within 4 weeks, or blood component(plasma component, platelet component) within 2 weeks.
- •Subjects who had a positive result for HIV antigen/antibody, HBs antigen, or HCV antibody, or a positive reaction to syphilis serology or urine drug test at screening.
- •Subjects with a positive for SARS-CoV-2 nucleic acid amplification test on the day of admission.
- •Subjects with symptoms of suspected COVID-19 (novel coronavirus infection).
- •Subject who is in the opinion of the investigator or sub-investigator, unsuitable in any other way to participate in this study.
结局指标
主要结局
-
Safety, Pharmacokinetics
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
SK-1887 P I (single-dose study)jRCT2071240130Sanwa Kagaku Kenkyusho Co.,Ltd.56
已完成
不适用
SK-5307 P I multiple-dose studyjRCT2071220064Sanwa Kagaku Kenkyusho Co.,Ltd.12
已完成
1 期
SK-5307 P I single-dose study.JPRN-jRCT2071220045Kenji Asano38
进行中（未招募）
1 期
Single Dose Study of MK-2060 in Japanese Older Participants on Dialysisend-stage renal diseaseJPRN-jRCT2041230025Tanaka Yoshiyuki16
已完成
1 期
FMI Food Effect Study of Doravirine/Islatravir (MK-8591A) in Healthy Japanese ParticipantsHealthy volunteerJPRN-jRCT2031200365Tanaka Yoshiyuki14