An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
研究概览
简要总结
Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be in good health
- •Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
排除标准
- •Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- •Has a history of cancer (malignancy)
- •Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)
研究组 & 干预措施
Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
干预措施: Probenecid (Drug)
Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
干预措施: MK-8527 (Drug)
Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
干预措施: MK-8527 (Drug)
Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
干预措施: MK-8527 (Drug)
Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
时间窗: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
时间窗: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
时间窗: Predose and at designated timepoints (up to 336 hours postdose)
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
次要结局
- Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food(Predose and at designated timepoints (up to 336 hours postdose))
- Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food(Predose and at designated timepoints (up to 336 hours postdose))
- Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food(Predose and at designated timepoints (up to 336 hours postdose))
- Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food(Predose and at designated timepoints (up to 336 hours postdose))
- Part 1: Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 43 days)
- Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 43 days)
- Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid(Predose and at designated timepoints (up to 336 hours postdose))
- Part 2: Tmax of MK-8527 in Plasma with and without Probenecid(Predose and at designated timepoints (up to 336 hours postdose))
- Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid(Predose and at designated timepoints (up to 336 hours postdose))
- Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid(Predose and at designated timepoints (up to 336 hours postdose))
- Part 2: Urine Concentration at 72 Hours of MK-8527(At designated timepoints (up to 72 hours postdose))
- Part 2: Renal Clearance of MK-8527(At designated timepoints (up to 72 hours postdose))
- Part 2: Number of Participants Who Experience an AE(Up to approximately 43 days)
- Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 43 days)
- Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole(Predose and at designated timepoints (up to 336 hours postdose))
- Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole(Predose and at designated timepoints (up to 336 hours postdose))
- Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole(Predose and at designated timepoints (up to 336 hours postdose))
- Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole(Predose and at designated timepoints (up to 336 hours postdose))
- Part 3: Urine Concentration at 72 Hours of MK-8527(At designated timepoints (up to 72 hours postdose))
- Part 3: Renal Clearance of MK-8527(At designated timepoints (up to 72 hours postdose))
- Part 3: Number of Participants Who Experience an AE(Up to approximately 43 days)
- Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 43 days)