EUCTR2018-002924-18-DE进行中（未招募）1 期
A Phase 1 Crossover Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet and Pediatric Azo Dye free Mini-tablet (Solid and Suspension) Compared to a Single Dose of Azo Dye-containing Tablet in Healthy Adult Subjects
Astellas Pharma Global Development, Inc. (APGD)0 个研究点目标入组 24 人开始时间: 2019年5月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Institutional review board/independent ethics committee-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for US sites) must be obtained and signed by the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Subject is a healthy male or female adult subject between 18 to 45 years of age, inclusive at screening.
- •3. Subject has a body mass index range of 18.5 to 30.0 kg/m2 , inclusive and weighs at least 50 kg at screening.
- •4. A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) OR
- •b. WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 28 days after the final study drug administration.
- •5. Female subject must agree not to breastfeed starting at screening and throughout the study period and for 28 days after the final study drug administration.
- •6. Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.
- •7. A male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 28 days after the final study drug administration.
- •8. A male subject must not donate sperm during the treatment period and for at least 28 days after the final study drug administration.
- •9. Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is (are) breastfeeding throughout the study period and for 28 days after the final study drug administration.
- •10. Subject agrees not to participate in another interventional study while participating in the present study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has received any investigational study drug within 28 days or 5 half-lives, whichever is longer, prior to screening.
- •2. Subject has any condition which, in the investigator’s opinion, makes the subject unsuitable for study participation.
- •3. Female subject who has been pregnant within 6 months prior to screening assessment or breastfeeding within 3 months prior to screening.
- •4. Subject has a known or suspected hypersensitivity to roxadustat or any components of the formulation used.
- •5. Subject has had previous exposure with roxadustat.
- •6. Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transferase and total bilirubin [TBL]) above the upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
- •7. Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study drug administration.
- •8. Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the investigator.
- •9. Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1.
- •10. Subject has any clinically significant abnormality following the investigator’s review of the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
- •11. Subject has a mean pulse < 50 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional measurement in triplicate can be taken.
- •12. Subject has a mean corrected QT interval using Fridericia’s formula (QTcF) of > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
- •13. Subject has used any prescribed or nonprescribed drugs (including vitamins, calcium and iron supplements, natural and herbal remedies, e.g., St. John’s Wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives and hormone replacement therapy.
- •14. Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months prior to screening.
- •15. Subject has a history of drinking more than 24 g/day of alcohol (10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) (> 12 g/day of alcohol for female subjects) within 3 months prior to day -1 or the subject tests positive for alcohol or drugs of abuse (amphetami
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