A Randomized, Double-Blind, Placebo-controlled, Single Continuous Intravenous Infusion Study of BMS-986231 to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Japanese and Non- Asian Participants

Bristol-Myers Squibb1 个研究点分布在 1 个国家目标入组 56 人开始时间: 2016年10月4日最近更新: 2017年5月31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: 56
试验地点: 1
主要终点: Safety and tolerability of single continuous IV infusion of BMS-986231 in healthy Japanese and Non-Asian participants based on Adverse events, clinical laboratory values, vital signs, ECGs, and physical examinations

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 Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•First generation Japanese
•Non-Asian with grandparents and parents of non-Asian descent
•Body weight greater than or equal to 45kg and less than or equal to 110kg
•Women of childbearing potential have specific birthcontrol methods
•Males sexually active with women of childbearing potential have specific birthcontrol methods

排除标准

•History of chronic illness
•Chronic headaches
•Recurrent dizziness
•Personal or family history of heart disease
•Personal history of bleeding diathesis