ISRCTN96285652已完成1 期
A phase 1, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeated daily doses of SFX-01 tablets in healthy male participants
Evgen Pharma (United Kingdom)0 个研究点目标入组 24 人开始时间: 2022年10月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 性别
- Male
入选标准
- •1. Participants who are able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate.
- •2. Participant must be 18 to 55 years of age inclusive, at the time of signing and dating the informed consent form (ICF).
- •3. Participants must be male.
- •4. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and 12-lead ECGs.
- •5. Participants must have a body mass index (BMI) of 18-32 kg/m2, with body weight in the range of 50-100 kg.
- •6. Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 90 days after last dose of IMP.
- •To be re-confirmed on Day -8 (prior to skin punch biopsy) and Day -1 (prior to first dose administration):
- •7. Participant continues to meet all screening inclusion criteria.
- •8. Participant has a negative urinary drugs of abuse (DOA)/alcohol screen.
- •9. Participant has a negative COVID-19 test (if required at the time of study conduct).
排除标准
- •1. Participants who are unable to refrain from eating brassica vegetables or using brassica containing supplements from at least 7 days prior to the Day -8 skin punch biopsies until the End of- Study Visit. Brassica vegetables include cabbage, cauliflower, horseradish, landcress, Ethiopian mustard, kale, collard greens, Chinese broccoli, cabbage, Brussels sprouts, Kohlrabi broccoli, broccoli flower, broccoli romanesco, wild broccoli, bok choy, Komatsuna, mizuna, rapini, flowering cabbage, Chinese cabbage, Napa cabbage, turnip root, rutabaga, canola/rape seed,
- •Siberian kale, wrapped heart mustard cabbage, mustard seed (brown, black, white), tatsoi, rocket (arugula), garden cress, water cress, radish, daikon, and wasabi.
- •2. Participants with a known sensitivity or intolerance to brassica vegetables.
- •3. Participants with any clinically relevant history (e.g., respiratory, renal, hepatic, GI, haematological, lymphatic, neurological, cardiovascular, psychiatric disease or diseases).
- •4. Participants with any clinically significant abnormal vital signs, physical examination, or other safety findings within 36 days before the first dose administration of the IMP.
- •5. Participants with any clinically significant abnormal test results for haematology, clinical chemistry, coagulation and/or urinalysis within 36 days before the first dose administration of the IMP.
- •6. Participants with gamma-glutamyl transferase (GGT) >1.5 x upper limit of normal (ULN).
- •7. Participants with disorders of the central nervous system, psychiatric disorders, and/or behavioural disturbances (e.g., cerebrovascular events, depression, post-traumatic stress disorder, anxiety, bipolar disorder, severe migraine, and Parkinson's disease).
- •8. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, within 36 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
- •9. Participants with a positive screen for Hepatitis B (Hepatitis B surface antigen [HBsAg]), Hepatitis C (Hepatitis C antibody, anti-Hepatitis C virus [HCV]), COVID-19 (lateral flow test [LFT]) or human immunodeficiency virus (HIV).
- •10. Participants with a history or clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 21 units if male. Drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
- •11. Participants who smoke more than 10 cigarettes or the equivalent amount of tobacco per day and/or regularly use vaping products and/or are unwilling to refrain from smoking/vaping during the study.
- •12. Participants with a confirmed positive result from urinary DOA screen at Screening, Day -8, or Day -1 indicating drug abuse including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, methadone, opiates, phencyclidine (PCP), and tricyclic
- •antidepressants, or a confirmed positive urine alcohol test at Screening, Day -8, or Day -1.
- •13. Participants who have received a COVID-19 vaccination within 28 days prior to the first dose or plan to receive a COVID-19 vaccination before the End-of-Stud
研究者
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