A Phase 1, Open-label Study Evaluating the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic drug-drug interactions, safety, and tolerability of co-administration of VX-993 and metformin in healthy participants.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Body mass index (BMI) of 18.0 to 32.0 Kilogram per square meter (kg/m^2)
- •A total body weight of more than (>) 50 Kg
- •Nonsmoker or ex-smoker for at least 3 months before the first study drug dose
排除标准
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VX-993 and Metformin
Metformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.
干预措施: VX-993 (Drug)
VX-993 and Metformin
Metformin will be administered to participants as a single oral dose on Day 1 and then co-administered with VX-993 on Day 10. VX-993 dose will be administered every 12 hours (q12h) from Day 5 through Day 14.
干预措施: Metformin (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
时间窗: From Day 1 up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993
时间窗: From Day 1 up to Day 14
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Metformin in Absence and Presence of VX-993
时间窗: From Day 1 up to Day 14
次要结局
- Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993(From Day 1 up to Day 14)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 29)
- Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993(From Day 1 up to Day 14)