A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
研究概览
简要总结
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
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
- Double (Participant, Investigator)
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
- •Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
- •Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
- •A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening
排除标准
- •Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
- •Inability to tolerate oral medication
- •Inability to tolerate venipuncture, or inadequate venous access
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Single Dose
Ascending single doses of BMS-986256
干预措施: BMS-986256 (Drug)
Single Dose
Ascending single doses of BMS-986256
干预措施: Placebo (Other)
Multiple Dose
Ascending multiple doses of BMS-986256
干预措施: BMS-986256 (Drug)
Multiple Dose
Ascending multiple doses of BMS-986256
干预措施: Placebo (Other)
Sequential Dose
Sequential multiple doses of BMS-986256
干预措施: BMS-986256 (Drug)
Sequential Dose
Sequential multiple doses of BMS-986256
干预措施: Placebo (Other)
结局指标
主要结局
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
时间窗: Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation
时间窗: Up to 44 days
Maximum concentration (Cmax)
时间窗: Up to 44 days
Time of maximum concentration (Tmax)
时间窗: Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
时间窗: Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
时间窗: Up to 44 days
Number of Serious Adverse Events (SAE)
时间窗: Up to 46 days
Number of deaths
时间窗: Up to 46 days
次要结局
- Metabolite ratio for AUC(TAU) [MR(AUC[TAU])](Up to 44 days)
- Terminal elimination rate constant (kel)(Up to 44 days)
- Terminal elimination half-life (T-half)(Up to 44 days)
- Apparent oral clearance (CL/F)(Up to 44 days)
- Metabolite ratio for AUC(INF) [MR(AUC[INF])](Up to 44 days)
- Metabolite ratio of Cmax [MR(Cmax)](Up to 44 days)
- Apparent volume of distribution at terminal phase (Vz/F)(Up to 44 days)
- Plasma concentration immediately prior to dosing (Ctrough)(Up to 44 days)
- Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)](Up to 44 days)
- Accumulation ratio of Ctrough [AR(Ctrough)](Up to 44 days)
- Accumulation ratio of AUC(TAU) [AR(AUC[TAU])](Up to 44 days)
- Accumulation ratio of Cmax [AR(Cmax)](Up to 44 days)