ACTRN12613000951752已完成1 期
A Phase I, Randomised, Double-Blind, Placebo-Controlled,AscendingSingle- and Repeat-Dose Study of the Safety,Tolerability andPharmacokinetics of Orally Administered PRN473
Clinical Network Services0 个研究点目标入组 114 人开始时间: 2013年8月27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
- 114
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.adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening
- •2. Body mass index (BMI) >18.0 and < 30.5 (kg/m2) (inclusive)
- •3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent
- •4. If male, agrees to be sexually abstinent or to use a condom or other adequate method of contraception
- •5. Female participants must be surgically sterile or post-menopausal
- •6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
排除标准
- •1. Pregnant or lactating females, and male partners of women who are pregnant or lactating
- •2. Females of child-bearing potential
- •3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
- •4. Any active acute or chronic disease judged to be clinically significant by the Investigator
- •5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to begining the study
- •6. History or presence of alcoholism or drug abuse within the 2 years prior to begining the study
- •7. History of any significant (as determined by the Invest
- •igator) drug-related allergic reactions
- •8. Use of any over-the-counter (OTC) medication
- •9. Participation in another clinical trial of a drug or device within 60 days.
- •10. Surgery within the past three months
- •11. Hypertension
- •12. Hypersensitivity to lactose
- •13. Regular alcohol consumption >14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •14. History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
- •15. Any acute illness within 30 days prior to Day 1 of the study
研究者
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