ACTRN12621000125820已完成1 期
A Multiple Dose Study Evaluating the Pharmacokinetics of an Oral Tablet Formulation of BNC210 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Agree to and be capable of signing informed consent form.
- •2. Adult males or females aged 18-65 years (inclusive) at the time of providing informed consent.
- •3. Body mass index within the range of 18-30 kg/m2 at screening
- •4. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.
- •5. Have suitable venous access for blood sampling.
- •6. Ability to swallow tablets
- •7. Females participants of childbearing potential who are not currently pregnant of breast feeding. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months prior to Screening and confirmed by follicle stimulating hormone (FSH) levels in menopausal range at Screening).
- •8. Agree to abstain from sexual intercourse or use a highly effective method of birth control if participant or partner of participant is of childbearing potential, for the duration of the study and for 3 months after the last dose of study drug. Highly effective methods of birth control include vasectomy, the use of a condom in combination with barrier methods, hormonal birth control (except oral contraception – see exclusion criterion 12) or intrauterine device. Requirement for contraception can be waived in certain circumstances (i.e. same sex relationships) if approved by the Sponsor.
排除标准
- •1. Any medical condition that in the opinion of the Investigator may adversely impact on the participant’s ability to complete the study.
- •2. Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min.
- •3. Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation.
- •4. Plasma AST (aspartate transaminase), ALT (alanine transaminase), and ALP (alkaline phosphatase) tests in excess of 1.5 times the upper limit of normal at screening or Day -1.
- •5. History of severe allergic or anaphylactic drug-related reactions.
- •6. Known past or present mental health disorder.
- •7. Concurrent use of any prescription medication, over the counter medication or complementary / alternative medication within 2 weeks prior to first dose.
- •8. Consumption of grapefruit, grapefruit juice, red wine or St. John’s Wort within 2 weeks prior to first dose.
- •9. Participation in another clinical trial of an investigational agent within 30 days of study entry.
- •10. Known history of past or present infection with hepatitis C virus (HCV), hepatitis B (HBV) or human immunodeficiency virus (HIV) or a positive test for HCV, HBV or HIV at screening.
- •11. Females who are pregnant, nursing, or intend to become pregnant during the study or within 3 months of their last dose of BNC210, or any males who plan to father/conceive a child within 3 months of their last dose of BNC210.
- •12. Females who are currently taking oral hormonal contraception (except progestogen only contraception (e.g., minipill”), including levonorgestrel-releasing intrauterine devices)
- •13. Clinically significant abnormal ECG (12-lead) at the Screening Visit as determined by the Investigator.
- •14. Participants who have a marked prolongation of the QTcF corrected interval (i.e., repeated demonstration of a QTcF interval >450 msec for males and >470 msec for females at Screening.
- •15. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
- •16. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant returning for visits on schedule.
- •17. Blood donation (1 unit or more) within 1 month prior to the Screening Visit.
- •18. Smoked cigarettes/e-cigarettes, tobacco and/or tetrahydrocannabinol containing products within 2 weeks prior to first dose.
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