NCT03142165已完成1 期
A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2017年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- •Weight within the range of ≥60 and ≤90 kg
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- •WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
排除标准
- •History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
- •History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
- •History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
- •Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
- •History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986263
Experimental
干预措施: BMS-986263 (Drug)
BMS-986263
Experimental
干预措施: Diphenhydramine (Drug)
BMS-986263
Experimental
干预措施: Famotidine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Placebo
Placebo Comparator
干预措施: Diphenhydramine (Drug)
Placebo
Placebo Comparator
干预措施: Famotidine (Drug)
结局指标
主要结局
Adverse Events (AE)
时间窗: 28 days
measured by incidences
Abnormalities in clinical laboratory tests
时间窗: 28 days
measured by incidences
Serious Adverse Events (SAE)
时间窗: 30 days
measured by incidences
Infusion related reactions
时间窗: 28 days
measured by incidences
Abnormal electrocardiogram measurements
时间窗: 28 days
measured by incidences
Abnormal vital sign measurements
时间窗: 28 days
measured by incidences
Physical examination abnormalities
时间窗: 28 days
measured by incidences
次要结局
- T-HALF(28 days)
- Cmax(28 days)
- CLT(28 days)
- AUC(0-T)(28 days)
- Tmax(28 days)
- AI_AUC(28 days)
- Ctrough(28 days)
- T-HALFeff_AUC(28 days)
- Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients(28 days)
- AUC(TAU)(28 days)
研究者
研究点 (1)
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