A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

Bristol-Myers Squibb1 个研究点分布在 1 个国家目标入组 41 人开始时间: 2014年8月最近更新: 2015年9月18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: 41
试验地点: 1
主要终点: Incidence of all adverse events (AEs) / serious adverse events (SAEs)

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 primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects.

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: 18 Years 至 49 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
•Men ages 18 to 49 years, inclusive

排除标准

•Any acute or chronic medical illness judged to be clinically-significant by the Investigator and/or Sponsor medical monitor
•Presence of fecal occult blood at screening
•History of prolonged occupational exposure to organic solvents or pesticides
•History of vitamin B12 deficiency and/or achlorhydria; or a vitamin B12 level at screening <lower limit of normal (LLN), confirmed by repeat test
•History of Guillain-Barré Syndrome
•Past or current history of central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesias (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities. Note: Experiencing an extremity "falling asleep" occasionally is not be exclusionary
•Clinically significant abnormality in the neurological exam at baseline (predose)
•Clinically significant nerve electrophysiology abnormalities at baseline (predose)
•Any history of testicular or epididymal disease/disorder
•Clinically significant abnormality on ophthalmologic exam or any findings suggesting an increased risk of macular edema at baseline (predose)
•History of hypothyroidism or carpal tunnel syndrome
•Subjects with history of diabetes mellitus
•Subjects with history of any type of heart disease, including ischemia, infarction, arrhythmias, hypertension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
•Subjects with any acute or chronic bacterial, fungal or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
•Subjects who have received any live vaccines within 1 month of study drug administration or who plan to have a live vaccine at any time during the study
•Positive test for tuberculosis at screening (QuantiFERON® GOLD)