A Three-Part Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of MK-1084 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
研究概览
简要总结
The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- •Medically healthy with no clinically significant medical history.
排除标准
- •Has a history of cancer.
- •Has had major surgery and/or donated or lost significant volume of blood.
研究组 & 干预措施
Calderasib Treatment A
Participants will receive calderasib on Day 1 on an empty stomach
干预措施: Calderasib (Drug)
Calderasib Treatment B
Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast
干预措施: Calderasib (Drug)
Calderasib Treatment C
Participants will receive calderasib Formulation 1 on Day 1
干预措施: Calderasib (Drug)
Calderasib Treatment D
Participants will receive calderasib Formulation 2 on Day 1
干预措施: Calderasib (Drug)
Calderasib Treatment E
Participants will receive calderasib without a PPI on Day 1
干预措施: Calderasib (Drug)
Calderasib Treatment F
Participants will receive calderasib with a PPI on Day 5
干预措施: Calderasib (Drug)
Calderasib Treatment F
Participants will receive calderasib with a PPI on Day 5
干预措施: PPI (Drug)
结局指标
主要结局
Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-last of calderasib.
Formulation Effect: AUC0-inf of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Calderasib
时间窗: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of calderasib.
Formulation Effect: Cmax of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib
时间窗: 24 hours postdose
Blood samples will be collected to determine the C24 of calderasib.
Formulation Effect: Lag Time (tlag) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the tlag of calderasib.
Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Tmax of calderasib.
Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the t1/2 of calderasib.
Formulation Effect: Apparent Clearance (CL/F) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the CL/F of calderasib.
Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Vz/F of calderasib.
Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the AUC0-inf of calderasib.
PPI Effect: Cmax of Calderasib
时间窗: At designated timepoints (up to 48 hours postdose)
Blood samples will be collected to determine the Cmax of calderasib.
次要结局
- Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE)(Up to approximately 2 months)
- Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE(Up to approximately 2 months)
- Formulation Effect: Number of Participants Who Experience a TEAE(Up to approximately 2 months)
- Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE(Up to approximately 2 months)
- PPI Effect: Number of Participants Who Experience a TEAE(Up to approximately 2 months)
- PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE(Up to approximately 2 months)
- Food Effect: AUC0-last of Calderasib(At designated timepoints (up to 48 hours postdose))
- Food Effect: AUC0-24 of Calderasib(At designated timepoints (up to 24 hours postdose))
- Food Effect: C24 of Calderasib(24 hours postdose)
- Food Effect: tlag of Calderasib(At designated timepoints (up to 48 hours postdose))
- Food Effect: Tmax of Calderasib(At designated timepoints (up to 48 hours postdose))
- Food Effect: t1/2 of Calderasib(At designated timepoints (up to 48 hours postdose))
- Food Effect: CL/F of Calderasib(At designated timepoints (up to 48 hours postdose))
- Food Effect: Vz/F of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: AUC0-last of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: AUC0-24 of Calderasib(At designated timepoints (up to 24 hours postdose))
- PPI Effect: C24 of Calderasib(24 hours postdose)
- PPI Effect: tlag of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: Tmax of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: t1/2 of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: CL/F of Calderasib(At designated timepoints (up to 48 hours postdose))
- PPI Effect: Vz/F of Calderasib(At designated timepoints (up to 48 hours postdose))