A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration
研究概览
简要总结
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has body mass index (BMI) between 18 and 32 kg/m^2, inclusive
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- •Has history of cancer (malignancy).
- •Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
研究组 & 干预措施
MK-8527 PLUS Moxifloxacin and Placebo
Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.
干预措施: Moxifloxacin (Drug)
MK-8527 PLUS Moxifloxacin and Placebo
Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.
干预措施: Placebo (Drug)
MK-8527 PLUS Moxifloxacin and Placebo
Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.
干预措施: MK-8527 (Drug)
Moxifloxacin PLUS MK-8527 and Placebo
Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.
干预措施: MK-8527 (Drug)
Moxifloxacin PLUS MK-8527 and Placebo
Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.
干预措施: Moxifloxacin (Drug)
Moxifloxacin PLUS MK-8527 and Placebo
Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.
干预措施: Placebo (Drug)
Placebo PLUS MK-8527 and Moxifloxacin
Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.
干预措施: MK-8527 (Drug)
Placebo PLUS MK-8527 and Moxifloxacin
Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.
干预措施: Moxifloxacin (Drug)
Placebo PLUS MK-8527 and Moxifloxacin
Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration
时间窗: Baseline and up to approximately 24 hours
Change from Baseline in QTc following MK-8527 administration will be reported.
次要结局
- Number of participants who experience one or more adverse events (AEs)(Up to approximately 7 weeks)
- Number of participants who discontinue study intervention due to an AE(Up to approximately 7 weeks)
- Change from Baseline in QTc following moxifloxacin administration(Baseline and up to approximately 24 hours)
- Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527(At designated timepoints (up to 24 hours postdose))
- Time to maximum plasma concentration (Tmax) of MK-8527(At designated timepoints (up to approximately 7 weeks))
- Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527(At designated timepoints (up to 168 hours postdose))
- Maximum plasma concentration (Cmax) of MK-8527(At designated timepoints (up to approximately 7 weeks))
- Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527(At designated timepoints (up to approximately 7 weeks))