A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2748 in Hepatitis C-Infected Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Number of participants experiencing clinical or laboratory adverse events (AEs)
研究概览
简要总结
This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panel A: GT1, low dose
Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.
干预措施: MK-2748 (Drug)
Panel A: GT1, low dose
Participants with genotype 1 (GT1) Hepatitis C Virus (HCV) will receive low dose MK-2748 daily for 7 days.
干预措施: Placebo (Drug)
Panel B: GT1, lower dose
Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.
干预措施: MK-2748 (Drug)
Panel B: GT1, lower dose
Participants with GT1 HCV will receive lower dose MK-2748 daily for 7 days.
干预措施: Placebo (Drug)
Panel C: GT1, dose based on Panels A+B
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).
干预措施: MK-2748 (Drug)
Panel C: GT1, dose based on Panels A+B
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose) and B (lower dose).
干预措施: Placebo (Drug)
Panel G: GT1, dose based on Panels A+B+C
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.
干预措施: MK-2748 (Drug)
Panel G: GT1, dose based on Panels A+B+C
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), and C.
干预措施: Placebo (Drug)
Panel I: GT3, dose based on Panels E+F
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.
干预措施: Placebo (Drug)
Panel H: GT1, dose based on Panels A+B+C+G
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.
干预措施: MK-2748 (Drug)
Panel H: GT1, dose based on Panels A+B+C+G
Participants with GT1 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels A (low dose), B (lower dose), C, and G.
干预措施: Placebo (Drug)
Panel D: GT3, low dose (Omitted)
Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.
干预措施: MK-2748 (Drug)
Panel D: GT3, low dose (Omitted)
Participants with genotype 3 (GT3) HCV were to receive low dose MK-2748 daily for 7 days. Panel D was omitted from the study design and participants were not enrolled in this panel.
干预措施: Placebo (Drug)
Panel E: GT3, high dose
Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
干预措施: MK-2748 (Drug)
Panel E: GT3, high dose
Participants with genotype 3 (GT3) HCV will receive high dose MK-2748 daily for 7 days.
干预措施: Placebo (Drug)
Panel F: GT3, dose based on Panel E
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).
干预措施: MK-2748 (Drug)
Panel F: GT3, dose based on Panel E
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panel E (high dose).
干预措施: Placebo (Drug)
Panel I: GT3, dose based on Panels E+F
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose) and F.
干预措施: MK-2748 (Drug)
Panel J: GT3, dose based on Panels E+F+I
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.
干预措施: MK-2748 (Drug)
Panel J: GT3, dose based on Panels E+F+I
Participants with GT3 HCV will be dosed with MK-2748 daily for 7 days based on the safety, pharmacokinetic, and/or pharmacodynamic data from Panels E (high dose), F, and I.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants experiencing clinical or laboratory adverse events (AEs)
时间窗: From first dose up to 21 days
Number of participants discontinued from study treatment due to AEs
时间窗: From Day 1 through Day 7
Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants
时间窗: Predose on Day 1 through Day 56
Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants
时间窗: Predose on Day 1 through Day 56
次要结局
- Plasma concentration of MK-2748 (C24) on Day 7 of dosing(24 hours post-dose on Day 7)
- Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748(Day 1 and Day 7, predose through 24 hours post-dose)