A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects

CrystalGenomics, Inc.1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2010年6月最近更新: 2016年1月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 120
试验地点: 1
主要终点: Safety (normal results for safety tests)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

详细描述

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 19 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table.
•No significant congenital/chronic disease. No symptoms in physical examination.
•Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
•Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

排除标准

•History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
•History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
•History of known hypersensitivity to drugs including CG
•After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).