JPRN-jRCT2080224955已完成1 期
A single-center, open-label, add-on drug-drug interaction trial to investigate the effects of single oral administration of rifampicin on the pharmacokinetics of OPC-61815 as a single intravenous administration in healthy male subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
Overall, there were no new safety concerns identified taking OPC-61815, either alone or in combination with rifampicin.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1) Japanese male subjects age 20 to 45 years, inclusive
- •2) Body Mass Index (BMI): at least 18.5 kg/m2 and less than 25.0 kg/m2
- •3) Subjects determined to have a genotype SLCO1B1 521T/T as a result of
- •genetic testing for OATP1B1
排除标准
- •Subjects with a history of clinically significant abnormality, or for whom a clinically significant abnormality is observed in the results of the screening examination, for which the investigator, subinvestigator, or sponsor judges that the abnormality could place the subject at risk or affect evaluation of drug absorption, distribution, metabolism, or excretion. Such abnormalities include, but are not limited to, a history or current symptoms of cardiac, hepatic, renal, nervous, endocrine, gastrointestinal, respiratory, hematologic, and immune diseases/disorders.
研究者
相似试验
已完成
1 期
Phase1 study of OPC-61815Congestive heart failureJPRN-jRCT2080223877Otsuka Pharmaceutical Co., Ltd.48
已完成
2 期
To investigate the efficacy and safety of OPC-6535 in COPD patientschronic obstructive pulmonary diseaseJPRN-jRCT2080220742Otsuka Pharmaceutical Co., Ltd.772
已完成
2 期
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart FailureCongestive heart failureJPRN-jRCT2080223620Otsuka Pharmaceutical Co., Ltd.61
招募中
不适用
A phase 1, multicenter, open-label, safety study of AG-120 or AG-221 in combination with induction therapy and consolidation therapy in patients with newly diagnosed acute myeloid leukemia with an IDH1 and/or IDH2 mutatioacute myelogenous leukemia10024324NL-OMON53153Institut de Recherches Internationales Servier (I.R.I.S)20
已完成
3 期
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral IntakeCongestive heart failureJPRN-jRCT2080224643Otsuka Pharmaceutical Co., LTD.45