A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) Inhibition in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Metformin
研究概览
简要总结
The main purpose of this study is to evaluate the effect of multiple doses of vimseltinib on the pharmacokinetics (PK) of a clinical OCT2 substrate (metformin) in healthy male participants. This study will also assess the safety and tolerability when vimseltinib is co-administered with the clinical OCT2 substrate (metformin) in healthy male participants. This study will last approximately 25 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) from 18 to 32 kilogram per square meter (kg/m^2).
- •Participants are in good general health, as required by the protocol and as determined by Principal Investigator.
- •Adequate organ function and blood and urine tests, as required by the protocol and as determined by Principal Investigator.
排除标准
- •History or presence of clinically significant diseases of the neurological, dermatological, renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems and/or history or presence of clinically significant psychiatric, immunological, endocrine, or metabolic disease in the opinion of the Investigator.
- •Unwilling or unable to comply with the requirements of the protocol.
- •Determined by Principal Investigator to be unsuitable to participate in the study for any other reason.
研究组 & 干预措施
Metformin + Vimseltinib
Metformin as single dose will be administered on Day 1 and Day 6. Vimseltinib will be administered every day (QD) on Days 3 through 6
干预措施: Vimseltinib (Drug)
Metformin + Vimseltinib
Metformin as single dose will be administered on Day 1 and Day 6. Vimseltinib will be administered every day (QD) on Days 3 through 6
干预措施: Metformin (Drug)
结局指标
主要结局
Pharmacokinetic (PK): Maximum Observed Plasma Drug Concentration (Cmax) of Metformin
时间窗: Predose up to 48 hours postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Metformin
时间窗: Predose up to 48 hours postdose
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline through Day 25)