ACTRN12621001003864已完成1 期
A Phase 1, randomized study to evaluate the safety, tolerability, and pharmacokinetics (PK) of the effects of food on the bioavailability of ONC201 following oral administration in healthy adult subjects - Part 2b
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions in this protocol.
- •2. Male or female between 18 to 55 years of age.
- •3. 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, tubal ligation or placement of bilateral fallopian tube occlusion, or with medically documented ovarian failure.
- •4. Males must be surgically sterilized OR must agree to use an acceptable method(s) of contraception during heterosexual intercourse with a female partner capable of becoming pregnant while enrolled in the study
- •5. Males must agree to refrain from sperm donation during the study and for at least 90 days after study drug administration.
- •6. Body mass index from 18 to 32 kg/m2, inclusive.
- •7. Participants who are overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, Physical Exam, laboratory tests, vital signs, and cardiac monitoring.
排除标准
- •1.If male, have a female partner who is pregnant or planning to become pregnant during the study or within 90 days after study drug administration.
- •2.Have received any investigational drug, agent, or device within 30 days prior to Day 1, or current participation in another investigational study.
- •3. Have a positive result for Hepatitis B/C or HIV.
- •4. Have a positive test for drugs of abuse, cotinine, and/or alcohol
- •5. Current history of heavy tobacco/nicotine use.
- •6. Any serious or active medical or psychiatric illness, which could interfere with participant treatment, assessment, or compliance with the protocol.
- •7. Have a history of a gastrointestinal condition that could interfere with the absorption of the study drug
- •8. Have a history or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease.
- •9. Have a history of hematological disorders, including disorders such as a bleeding disorder or a risk of gastrointestinal bleeding.
- •10. Have a history of chronic liver disease or hepatic impairment,
- •11. Total bilirubin greater than the upper limit of the normal reference range at screening or on Period 1 Day -1.
- •12. Have symptoms of acute infection within 2 weeks prior to Period 1 Day 1.
- •13. Have clinically significant abnormal hemoglobin as determined by the investigator at the screening evaluation
- •14. Have donated a unit of blood or had clinically significant blood loss within 30 days prior to Period 1 Day 1 or donated plasma within 7 days prior to Period 1 Day 1.
- •15. Have received any prescription medication, vaccines, or any nonprescription medication (including vitamins and herbal products) within 14 days prior to Period 1 Day 1
研究者
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