ACTRN12611000228987已完成1 期
A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Edaravone + (+)-Borneol When Administered Intravenously in Healthy Subjects
Medpace Australia Pty Limited0 个研究点目标入组 48 人开始时间: 2011年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy adult male and female subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;
- •2. Body weight greater than or equal to 50 kg and body mass index (BMI) within the range 18-30 kg/m2, inclusive, at screening;
- •3. Medically healthy subjects with clinically insignificant screening and check-in results (medical histories, 12-lead ECG, physical exam, and laboratory tests);
- •4. Women of childbearing potential with a negative urine pregnancy test at screening and check-in who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control during the study;
- •5. Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 30 days following the last administration of study drug;
- •6. Female subjects, if of child-bearing potential, must agree to use an acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) in addition to having their male partner use barrier contraception (condom with spermicide) from first dose until 30 days following the last administration of study drug. Female subjects who are NOT of child-bearing potential include those who have a history of tubal ligation, hysterectomy, or bilateral salpingooopherectomy, or who have had no menstrual period for >12 months, confirmed by a screening follicle stimulating hormone (FSH) level in the postmenopausal range;
- •7. Hemoglobin level within normal limits (WNL) of the reference laboratory (one repeat is allowed for a hemoglobin level that falls within 0.3 g/dL of the upper or lower limit of the reference range); and
- •8. Subjects who are able to understand and to give their signed informed consent before any trial related procedures are performed.
排除标准
- •1. Subjects with, or a history of, cancer (not including basal cell skin cancer greater than 5 years prior), diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, neurological, psychiatric or other major
- •2. Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
- •3. Systolic blood pressure (SBP) outside the range of 90 to 140 mmHg, diastolic blood pressure (DBP) outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm at screening or check-in. One repeat blood pressure measurement may be performed if SBP is between 141 and 150 mmHg or DBP is between 91 and 95;
- •4. Clinically significant abnormality on ECG in the judgment of the Investigator;
- •5. Microscopic hematuria defined as >5 red blood cells (RBC) per high powered field (HPF) in a male or a non-menstruating female; 1 repeat allowed within several days of screening, including (but not limited to) females who are menstruating at the time of screening;
- •6. Reticulocyte value (percent reticulocytes) of more than 1% above the upper limit of normal (ULN) for the reference laboratory;
- •7. Urine protein > trace on a standard dip stick test (1 repeat allowed);
- •8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the ULN;
- •9. Oxygen saturation by pulse oximetry <95%;
- •10. History of clinically significant drug and/or food allergies as determined by the Principal Investigator (PI);
- •11. History of clinically significant cardiac arrhythmia;
- •12. Subject is not willing to abstain from alcohol for 48 hours prior to the start of the first dose until completion of the post-study follow-up assessments;
- •13. Average weekly alcohol intake of greater than 21 units or an average daily intake of greater than 3 units (One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.);
- •14. Recent history (within 2 years) or currently diagnosed alcohol or drug abuse, in the judgement of the Investigator;
- •15. Tobacco or nicotine replacement product use within the 6 months prior to first dose through the follow-up visit, or a positive urine screen for cotinine;
- •16. Hypersensitivity or idiosyncratic reaction to compounds related to the study drug;
- •17. Use of substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 14 days prior to the first dose;
- •18. Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication;
- •19. Consumption of food or beverage containing grapefruit or cranberry within 7 days prior to the first dose of study medication;
- •20. Donation of whole blood in excess of 500 mL within 30 days prior to check-in;
- •21. Plasma donation within 7 days prior to check-in;
- •22. Subject participated in an investigational clinical study within 30 days (of last dose of previous study drug) prior to the first dosing, or within days calculated as 10 times the half-life of the compound that the subject was treated with, whichever is longer or participated in the early cohorts of the current study. Factors other than the half-life of the compound, such as accumulation of tissue, muscle or organ, should also be considered
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