JPRN-jRCT2071210091已完成1 期
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of S-001000 by dose-titration method in Japanese Healthy Adult Male Subjects(twice-daily oral administration)
Tsubouchi Ichiro0 个研究点目标入组 12 人开始时间: 2021年11月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
o problem was observed in the safety and tolerability of repeated oral administration of S-001000 30 to 120 mg/day twice daily for total 20 days by a dose-escalation method. Cmax and AUC increased in proportion to the dose and their linearity were observed. Steady state was almost reached after the second dosing day of each dose level and no accumulation was observed based on pharmacokinetics such as Ctrough and R. The reduction in serum uric acid levels was maintained in terms of pharmacodynamics.
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 healthy male aged >= 20 and <= 45 years at the time of informed consent.
- •(2)Subjects with screening body mass index (BMI) >= 18.5 kg/m2 to < 28.0 kg/m2.
- •(3)Subjects considered healthy by the investigator/subinvestigator based on the results of screening examination, and medical examination and all tests performed after admission and before study drug administration.
- •(4)Subjects who are fully informed of the study objectives, contents, and study drug, and voluntarily provide a written consent to participate in the study.
排除标准
- •(1)Subjects with a current or past history of a clinically concerned gastrointestinal, hepatic, musculoskeletal, respiratory, cerebrovascular or cardiovascular, hematological, oncological, endocrine, immunological, psychiatric, neurological, or urogenital disease, or any condition that, in the opinion of the investigator/subinvestigator, would compromise the subject's safety or interfere with this study results.
- •(2)Subjects with a current or past history of urinary calculus.
- •(3)Subjects with a history of surgery or a current internal medical condition that, in the opinion of the investigator/subinvestigator, may interfere with drug absorption, distribution, metabolism, or excretion.
- •(4)Otherwise, subjects who are judged by the investigator/subinvestigator to be ineligible for the study.
研究者
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