NCT02055716已完成1 期
A Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects Following Daily Dosing for 7 Days
Evgen Pharma1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing
详细描述
This study will be conducted in a randomised, double-blind, placebo-controlled design with multiple ascending doses of Sulforadex® administered qd [once daily] or bid [twice daily]) to healthy male subjects between 18 to 45 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is a healthy male of any race aged 18 to 45 years, inclusive, at screening.
- •Subject has a BMI of 18 - 25 kg/m2 inclusive at screening.
- •Subjects must agree to use acceptable methods of contraception,
- •Subjects should not donate sperm from the time of the first administration of treatment or study medication until 3 months following administration of the last treatment or dose of study medication.
- •Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to undergoing any study-related procedures.
排除标准
- •All subjects must refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration. Brassica vegetables include cabbage, cauliflower, horseradish, landcress, Ethiopian mustard, kale, collard greens, Chinese broccoli, 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.
- •Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
- •Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
- •ECG abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis.
- •History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
- •Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti Hepatitis core antibody (anti HBc Ig G [and anti HBc IgM if IgG is positive], Hepatitis C virus antibodies (anti HCV), and human immunodeficiency virus HIV 1 and 2 antibodies (anti HIV 1/2).
- •Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening and on admission (Day -1).
- •History or clinical evidence of alcohol or drug abuse.
- •Mentally handicapped.
研究组 & 干预措施
alpha-cyclodextrin
Placebo Comparator
A placebo comparator composed of the same acid resistant HPMC capsules filled with 300mg of alpha cyclodextrin
干预措施: alpha-cyclodextrin (Drug)
Sulforadex
Experimental
100mg or 300mg size 00 acid resistant HPMC capsules
干预措施: Sulforadex (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 7 days
Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.
次要结局
- Area under the plasma concentration versus time curve (AUC) of sulforaphane(time 0, 30 min 1 2 4 8 12 & 24 hrs post dose on days 1,2 & 7)
研究者
研究点 (1)
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