ISRCTN13564773已完成1 期
A double-blind, placebo-controlled, single and multiple ascending dose phase I study to evaluate the safety, tolerability, and pharmacokinetics of CCX168 in healthy male and female subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27768695 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects, aged 19-45 years inclusive, who are in generally good health, whose body mass index is 19 to 29 kg/m^2
- •2. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- •3. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen
- •4. Judged to be healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study.
- •5. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication
排除标准
- •1. Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening and/or on Study Day -1
- •2. Expected requirement for use of any medication (with the exception of continuing use by female subjects of hormonal contraceptives in accordance with a regimen that has been stable for at least the three months prior to Screening) during the study period
- •3. History within the three months prior to study entry of use of tobacco and/or nicotine-containing products
- •4. History within one year prior to study entry of illicit drug use
- •5. History of alcohol abuse at any time in the past
- •6. History of any form of cancer
- •7. Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit juice within 24 hours of screening
- •8. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation
- •9. Donated or lost more than 350 mL of blood or blood products within 56 days prior to screening, or donated plasma within 7 days of randomization
- •10. Subject's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L)
- •11. Participated in any clinical study of an investigational product within 30 days prior to randomization
- •12. Subject has any evidence of hepatic disease; AST, ALT, GGT, alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal
- •13. Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal
- •14. Subject's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol)
研究者
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