NCT03936374已完成1 期
A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年5月8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
- 16
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of BMS-986205
研究概览
简要总结
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)
- •Body mass index (BMI) of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2
- •Women participants must have documented proof that they are not of childbearing potential
排除标准
- •Women who are of childbearing potential or breastfeeding
- •Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
- •Concomitant use of strong inhibitors or strong inducers of CYP3A4
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
研究组 & 干预措施
BMS-986205 + Omeprazole
Experimental
干预措施: BMS-986205 (Drug)
BMS-986205 + Omeprazole
Experimental
干预措施: omeprazole (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of BMS-986205
时间窗: Up to Day 29
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205
时间窗: Up to Day 29
Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
时间窗: Up to Day 29
次要结局
- Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation(Up to Day 36)
- Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities(Up to Day 29)
- Number of Participants with Physical Examination Abnormalities(Up to Day 29)
- Number of Participants with Vital Sign Abnormalities(Up to Day 29)
- Number of Participants with Clinical Laboratory Results Abnormalities(Up to Day 29)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Research of Efficient Use of Omeprazole in Combination With Domperidone in Gastroesophageal Reflux Disease of Mild to Moderate SeverityGERDNCT02140073Belarusian Medical Academy of Post-Graduate Education60
已完成
1 期
A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of IsavuconazolePharmacokinetics of IsavuconazoleHealthy SubjectsNCT02128893Astellas Pharma Global Development, Inc.24
已完成
1 期
A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each OtherHealthyNCT03905096Boehringer Ingelheim32
已完成
4 期
Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)Rhinitis, Allergic, PerennialNCT00806754AstraZeneca340
已完成
1 期
Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy SubjectsMalignant TumorNCT06093945Jiangsu HengRui Medicine Co., Ltd.20