NCT00947245撤回1 期
A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
- •First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry
排除标准
- •Any significant acute or chronic medical illness.
- •Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
- •Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
- •History of eczema, psoriasis, or any intermittent or active dermatitis.
- •Positive for HIV or HCV
研究组 & 干预措施
BMS-791325 - Part B, Dose 3
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part A, Dose 1
Experimental
干预措施: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 1
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part A, Dose 2
Experimental
干预措施: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 2
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part A, Dose 3
Experimental
干预措施: BMS-791325 (Drug)
BMS-791325 - Part A, Dose 3
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part B, Dose 1
Experimental
干预措施: BMS-791325 (Drug)
BMS-791325 - Part B, Dose 1
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part B, Dose 2
Experimental
干预措施: BMS-791325 (Drug)
BMS-791325 - Part B, Dose 2
Experimental
干预措施: Placebo (Drug)
BMS-791325 - Part B, Dose 3
Experimental
干预措施: BMS-791325 (Drug)
结局指标
主要结局
Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
时间窗: From time of dose to up to 14 days after last dose
次要结局
- To measure concentration of study drug following single and multiple doses(Within 48 or 72 hours postdose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy SubjectsRheumatoid ArthritisNCT02705989Bristol-Myers Squibb439
已完成
1 期
A Study of HNC042 in Healthy Chinese Subjects to Evaluate the Safety, Tolerability, and PharmacokineticsInfluenzaNCT04603989Guangzhou Henovcom Bioscience Co. Ltd.36
已完成
1 期
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 DiabetesPeripheral Diabetic NeuropathyDiabetes MellitusType 1 DiabetesNCT01293461Cebix Incorporated72
已完成
1 期
A Study of JNJ-61393215 in Healthy Japanese Male ParticipantsHealthyNCT04713930Janssen Pharmaceutical K.K.24
已完成
1 期
A Study of JNJ-40411813 in Healthy Japanese Male ParticipantsHealthyNCT04677530Janssen Pharmaceutical K.K.39