ACTRN12618002011268尚未招募1 期
An Open-Label, Single-Dose, Randomized, Two-Period, Crossover Study Evaluating the Absolute Bioavailability of Brincidofovir Administered as CMX001-P-SUS-HPI-010 Suspension Formulation Compared to CMX001-P-IVS-PPS-003 BCV Intravenous formulation in Healthy Japanese and Non-Japanese Adult Subjects
Chimerix Inc.0 个研究点目标入组 36 人开始时间: 2018年12月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Male or female between 18 to 70 years of age.
- •2. Born in Japan, have both parents and grandparents of Japanese origin, and lived for < 10
- •years outside of Japan (Part B only).
- •3. Non-Japanese (Part A only)
- •4. Female must be of non-childbearing potential, i.e., postmenopausal woman or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, tubal ligation or placement of bilateral fallopian tube occlusion or with medically documented ovarian failure.
- •5. . Males must be surgically-sterilized or agree to use two contraception methods during
- •heterosexual intercourse with a female partner capable of becoming pregnant.
- •6.Willing and able to provide written informed consent.
排除标准
- •. Have a positive pregnancy test at screening or Day -1.
- •2. Have received any investigational drug,or device within 30 days prior to study start
- •3. Have received BCV in a previous clinical trial.
- •4. Have a positive test result at the screening consistent infection with HBV, HCV, or HIV.
- •5. Have a positive test for drugs of abuse, cotinine, and/or alcohol .
- •6. History of tobacco/nicotine use (Part A only). [Note: Former tobacco/nicotine users are
- •eligible, provided the subject has not used a tobacco- or nicotine-containing product for a
- •minimum of 6 months prior to Period 1 Day 1.]
- •7. Have any serious or active medical or psychiatric illness,
- •8. Have a history of a gastrointestinal condition or disorder
- •9. Have a history or symptoms of cardiovascular disease,
- •10. Have a history of haematological disorders such as a bleeding disorder.
- •11. Have a history of chronic liver disease or hepatic impairment,
- •12. History of Gilbert’s syndrome or a total bilirubin greater than the upper limit of the
- •normal reference range
- •13.Have symptoms of infection (such as those experienced with a cold or flu,)
- •14. Have a history of difficulty with blood donation, including vasovagal syncope (fainting),
- •15. Have a clinically significant abnormal haemoglobin.
- •16. Have donated blood or had clinically significant blood loss within 30 days prior to study start
- •17. Have received any medication or herbal product known to induce or inhibit hepatic metabolizing enzymes
- •18. Have received any prescription medication within 14 days prior to Day 1,
- •19. Have received any non-prescription medication within 3 days prior to Day 1,
- •20. Have a history of clinically relevant drug or alcohol dependence within the past 2 years
- •21. Have consumed fruit juice within 3 days prior to Period 1 Day 1,
- •22. Any condition or set of circumstances that, in the judgment of the investigator, could
- •interfere with the subject’s ability to comply with completion of the study.
研究者
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