A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1972 in HIV-1 Infected Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
研究概览
简要总结
This is a two part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK-1972 in participants with HIV-1 infections. In Part 1, participants will be randomized to receive MK-1972 (at one of 5 different dose levels given once or twice per day) or placebo. Part II will begin after the results of Part I are known; participants will be randomized to receive MK-1972 (only one dose level, twice per day) or placebo. The primary hypotheses are that MK-1972 at the studied doses is safe and well tolerated in HIV-1 infected males; and that MK-1972 has superior antiretroviral activity compared to placebo.
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 55 Years（Adult）
- 性别
- Male
- 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
MK-1972 50 mg once daily (Part I)
Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: MK-1972 (Drug)
MK-1972 50 mg once daily (Part I)
Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
MK-1972 200 mg once daily (Part I)
Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: MK-1972 (Drug)
MK-1972 200 mg once daily (Part I)
Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
MK-1972 800 mg once daily (Part I)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: MK-1972 (Drug)
MK-1972 800 mg once daily (Part I)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
MK-1972 25 mg twice daily (Part I)
Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
干预措施: MK-1972 (Drug)
MK-1972 25 mg twice daily (Part I)
Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
MK-1972 100 mg twice daily (Part I)
Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
干预措施: MK-1972 (Drug)
MK-1972 100 mg twice daily (Part I)
Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
Placebo twice daily (Part I)
Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
干预措施: Placebo to MK-1972 (Drug)
MK-1972 800 mg twice daily (Part II)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)
干预措施: MK-1972 (Drug)
MK-1972 800 mg twice daily (Part II)
Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part II)
干预措施: Placebo to MK-1972 (Drug)
Placebo twice daily (Part II)
Ten capsules containing placebo were taken orally, twice per day for 10 days (Part II)
干预措施: Placebo to MK-1972 (Drug)
结局指标
主要结局
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
时间窗: From consent to 14 days after the last dose (up to Day 24)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an adverse event.
Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo
时间窗: Baseline and Day 10 (24 hours post-dose)
Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.
次要结局
- The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection(Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose)