ACTRN12610000442000已完成1 期
The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
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 65 Years（—）
- 性别
- Male
入选标准
- •1. Adult males 18-65 years
- •2. Good general health without significant renal, hepatic, cardiac or respiratory disease
- •3. Good general mental health as determined by scores on the Symptom Checklist 90-R
- •4. Agree to and be able to sign informed consent form
- •5. Have suitable venous access for blood sampling
- •6. Body mass index (BMI) within 19-30 kg/m2
排除标准
- •1. Renal impairment - creatine clearance less than 90 mL/min (Cockcroft-Gault method)
- •2. Laboratory value at screening outside the normal range, unless it is judged by investigator as not clinically significant after appropriate evaluation
- •3. Score of more than 2 standard deviations from the mean on any of the key 9 scales in the Symptom Checklist -90 - Revised (SCL-90-R)
- •4. Any medical condition that in the opinion of the investigator may adversely impact on ability to complete the study
- •5. Plasma Aspartate transaminase (AST), alanine transaminase (ALT), Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal
- •6. Laboratory evidence of clinically significant serum iron deficiency
- •7. History of severe allergic or anaphylactic drug-related reactions
- •8. Current (within last 6 months) clinically significant psychiatric disorder including anxiety or depression
- •9. Concurrent use of medication ona regular or daily basis
- •10. Participation in another clinical trial of an investigational agent within 30 days of study entry
- •11. Known history of past or present infection with hepatitis C virus, hepatitis B or human immuno-deficiency virus (HIV)
- •12. Clinically significant abnormal electrocardiogram (ECG) (12 lead) at screening visit or prior to dosing on Day 1 as determined by the investigator
- •13. Marked prolongation of the QTcB interval (ie repeated demonstration of QTcB interval >430 for males)at screening or prior to dosing on Day 1
- •14. Significant history of illicit drug or alcohol use or abuse within 1 year of screening
- •15. Any alcohol use with 24 hrs prior to dosing on Day 1
- •16. Unwillingness or inability to comply with requirements of the protocol
- •17. Blood donation (1 unit or more) within 1 month prior to screening
- •18. Smoke >5 cigarettes per day
- •19. Previous enrolment in study BNC210.001
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