NCT07629999招募中1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
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
- 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
- •Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg.
- •Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.
- •A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.
排除标准
- •Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).
- •Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
- •Participants must not have any major surgery within 3 months of study intervention administration.
- •Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).
- •Other protocol defined inclusion/exclusion criteria applies.
研究组 & 干预措施
Arm A
Experimental
干预措施: Placebo (Drug)
Arm B
Experimental
干预措施: BMS-986533 (Drug)
Arm B
Experimental
干预措施: Placebo (Drug)
Arm A
Experimental
干预措施: BMS-986533 (Drug)
Arm C
Experimental
干预措施: BMS-986533 (Drug)
Arm D
Experimental
干预措施: BMS-986533 (Drug)
Arm C
Experimental
干预措施: Famotidine (Drug)
Arm D
Experimental
干预措施: Rosuvastatin (Drug)
Arm D
Experimental
干预措施: Dabigatran Etexilate (Drug)
研究者
研究点 (1)
Loading locations...
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