A Two-Part, Single Rising Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MK-8723 in Healthy Adults and Patients With Immune Thrombocytopenia Purpura
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Number of Participants Experiencing an Adverse Event
研究概览
简要总结
The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to assess pharmacodynamics of MK-8723 in participants with ITP. The primary hypothesis is that the true placebo-adjusted platelet response rate to MK-8723 in adult patients with chronic ITP is >50%.
详细描述
In Part 1 of the trial, safety and pharmacokinetics of MK-8723 will be evaluated in healthy participants. In Part 2 of the trial, safety, pharmacokinetics, and pharmacodynamics will be evaluated among participants with ITP. In Part 1, dose escalation will occur in up to 5 serial panels of participants; each participant will receive a single intravenous (IV) dose of MK-8723 (or placebo). In Part 2, dose escalation will occur in up to 3 serial panels of participants with ITP; each participant will receive a single IV dose of MK-8723 (or placebo), once safety and tolerability of the corresponding dose is shown in Part 1. Amendment 3 specified a re-enrollment procedure for eligible participants in Part 2 to participate in more than one dosing panel.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 2: MK-8723 100 mg/kg in ITP Participants
MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
干预措施: MK-8723 (Drug)
Part 2: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
干预措施: Matching Placebo (Drug)
Part 1: MK-8723 1 mg/kg in Healthy Participants
MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
干预措施: MK-8723 (Drug)
Part 1: MK-8723 3 mg/kg in Healthy Participants
MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
干预措施: MK-8723 (Drug)
Part 1: MK-8723 10 mg/kg in Healthy Participants
MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
干预措施: MK-8723 (Drug)
Part 1: MK-8723 30 mg/kg in Healthy Participants
MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
干预措施: MK-8723 (Drug)
Part 1: MK-8723 100 mg/kg in Healthy Participants
MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
干预措施: MK-8723 (Drug)
Part 1: Matching Placebo to MK-8723
Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
干预措施: Matching Placebo (Drug)
Part 2: MK-8723 10 mg/kg in ITP Participants
MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
干预措施: MK-8723 (Drug)
Part 2: MK-8723 30 mg/kg in ITP Participants
MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
干预措施: MK-8723 (Drug)
结局指标
主要结局
Number of Participants Experiencing an Adverse Event
时间窗: Up to 84 days
An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Discontinuing Study Due to an Adverse Event (AE)
时间窗: Up to 84 Days
An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants With a Positive Platelet Response to MK-8723
时间窗: Up to Day 14
In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of \<50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.
次要结局
- Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP(All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84)
- Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP(All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84)