ACTRN12615000199516已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Analytically Masked Sequential-Panel, Ascending Single-Dose, and Repeated Twice Daily-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Analgesic Efficacy of Oral CMX-020 in Healthy Male and Female Subjects.
Cytometix Australia Pty Ltd0 个研究点目标入组 30 人开始时间: 2015年3月2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
- 30
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 50 Years（—）
- 性别
- All
入选标准
- •if female of child bearing potential; must be surgically sterile, or practicing a medically acceptable form of contraception. Must have a negative urine pregnancy test at screening and check-in and be non-lactating.
- •- if male; must agree to use a condom if engaging in sexual intercourse at any time during the study.
- •- good health as determined by a physician.
- •- clinical lab results within reference range unless results are deemed not clinically significant by Investigator or Sponsor, or normal upon retesting during the screening and check-in periods.
- •- BMI between 21 and 30 kg/m2, inclusive.
- •- negative urine toxicology screen for substances of abuse and a negative alcohol breath screen during screening and check-in.
- •- negative for hepatitis B surface antigen, hepatitis C antibody and HIV at screening visit.
- •- creatinine clearance of at least 70 mL/min during screening.
排除标准
- •- history of injury or disease involving either hand.
- •- history of drug or alcohol abuse within the past 2 years.
- •- previous history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for at least 5 years prior to dose of study drug.
- •- systolic BP >140 mm Hg or < 85 mm Hg, or diastolic BP > 90 or < 60 mm of Hg at screening or check-in.
- •- pulse > 100 beats/minute or < 55 beats /minute during screening or check-in.
- •- medical history of hypertension, hypotension or postural hypotension.
- •- history of any acute or chronic painful condition requiring frequent analgesic use.
- •- pain at the time of check-in or morning of Day 1 which would warrant analgesia during the study or potentially interfere with pain assessments.
- •- history or family history of seizure.
- •- history of head trauma requiring an ER visit, inpatient observation or hospitalization.
- •- history of syncope.
- •- history or clinical manifestations of significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders.
- •- clinically significant abnormal ECG at screening.
- •- history of long QT syndrome or a QTcF interval > 450 msec at screening.
- •- unwilling to abstain from grapefruit, grapefruit juice, or any caffeine-containing products or medications for 72 hours prior to study drug administration and throughout study.
- •- consumed alcohol within 72 hours prior to screening or baseline/check-in visits.
- •- used any tobacco products within 6 weeks prior to screening.
- •- dietary restrictionsand poor venous access.
- •- used any prescription, OTC, nutraceuticals, herbal or homeopathic medication or vitamins within 14 days prior to study drug administration.
- •- donated blood within 30 days prior to check-in visit.
- •- participated in an investigational study within past 30 days or 5 half lives of the investigational drug (whichever is longer) prior to study drug administration.
研究者
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