跳至主要内容
临床试验/jRCT2031230432
jRCT2031230432已完成不适用

The phase I mass balance study to investigate the pharmacokinetics of OP-724 following a single dose of 14C-labeled OP-724 in healthy male volunteers.

OHARA Pharmaceutical Co.,Ltd.0 个研究点目标入组 6 人开始时间: 2023年11月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
主要终点
-

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
Non-randomized Controlled Trial
干预模型
Single Assignment
主要目的
Other
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 45age old not(—)
性别
Male

入选标准

  • 1: Healthy Japanese male subjects.
  • 2: Age at the time of obtaining written informed consent is >=18 to <45 years old.
  • 3: Subjects who are capable of fully understanding the clinical trial and providing written informed consent.

排除标准

  • 1: Subjects with any clinilcal abnormality assessed by the investigator or subinvestigator in laboratory tests, vital signs, or 12-lead ECG in eligibility testing.
  • 2: Subjects with a QTcF of > 450 msec on a 12-lead ECG in the eligibility test.
  • 3: Subjects who weighs < 50.0 kg in the eligibility test.

结局指标

主要结局

-

Pharmacokinetics

次要结局

未报告次要终点

研究者

发起方
OHARA Pharmaceutical Co.,Ltd.

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