NCT01452607已完成1 期
A Phase 1, Double-blind, Placebo-controled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPI-1005 (Ebselen)in Healthy Adult Subjects
Sound Pharmaceuticals, Incorporated1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年5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
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male and female subjects
- •Within 15% of their ideal weights (Table of "Desirable Weights of Adults," Metropolitan Life Insurance Company, 1983)
- •Medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ECGs, physical exam);
- •Voluntarily consented to participate in the study;
- •Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to screening and throughout the study or used one of the following acceptable birth control methods: Intrauterine device (IUD) in place for at least 3 months prior to study; Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; Stable hormonal contraceptive for at least 3 months prior to study through completion of study; Surgical sterilization (vasectomy) of partner at least 6 months prior to study. Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease;
- •History or presence of alcoholism or drug abuse within the past 2 years;
- •Hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
- •Use of any prescription medication within 14 days (with the exception of hormonal contraceptives) prior to or during the study;
- •Use of any over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior or during the study;
- •Use of any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 28 days prior to dosing;
- •Abnormal diet (for any reason) during the 30 days prior to dosing;
- •Donation of whole blood within 56 days prior to the study;
- •Plasma donation within 7 days prior to the study;
- •Participation in another clinical trial within 30 days prior to the study;
- •Female subjects who were pregnant or lactating;
- •Hemoglobin < 12.0 g/dL;
- •Orthostatic vital signs which result in: A pulse increase of more than 30 beats per minute after 3 minutes standing (compared with semi-recumbent pulse rate); or A pulse rate greater than 100 bpm after 3 minutes standing; or A drop in systolic blood pressure decrease of at least 20 mm Hg; or A diastolic blood pressure decrease of at least 10 mm Hg within 3 minutes of standing (compared with semi-recumbent blood pressure).
研究组 & 干预措施
SPI-1005 Capsule 200mg Ebselen x2
Experimental
2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose
干预措施: SPI-1005 (Drug)
SPI-1005 Capsule 200mg Ebselen x1
Experimental
Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose
干预措施: SPI-1005 (Drug)
SPI-1005 Capsule 200mg Ebselen x4
Experimental
4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose
干预措施: SPI-1005 (Drug)
SPI-1005 Capsule 200mg Ebselen x8
Experimental
8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose
干预措施: SPI-1005 (Drug)
SPI-1000 Capsule 0 mg Ebselen Placebo
Placebo Comparator
Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 1 month
The primary objective of this study was to evaluate the safety and tolerability of SPI-1005 (ebselen) in healthy subjects. Incidence and severity of Adverse Events were determined in all treatment and placebo groups.
次要结局
- Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects(24 hours)
研究者
研究点 (1)
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