A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of MK-8507 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
- 62
- 试验地点
- 1
- 主要终点
- Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration
研究概览
简要总结
Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1
The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Is in good health before randomization
- •Has body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
排除标准
- •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 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
Moxifloxacin 400 mg + Placebo (Arm 1)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.
干预措施: Moxifloxacin Placebo (Drug)
Moxifloxacin 400 mg + Placebo (Arm 1)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.
干预措施: Ulonivirine Placebo (Drug)
Ulonivirine Dose 1 + Placebo (Arm 2)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.
干预措施: Moxifloxacin Placebo (Drug)
Ulonivirine Dose 1 + Placebo (Arm 2)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.
干预措施: Ulonivirine (Drug)
Ulonivirine Dose 1 + Placebo (Arm 2)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.
干预措施: Ulonivirine Placebo (Drug)
Moxifloxacin 400 mg + Placebo (Arm 1)
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration
时间窗: Baseline and up to approximately 24 hours
Change from baseline in QTc following ulonivirine administration will be reported.
Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc)
时间窗: At designated timepoints (up to approximately 24 hours)
Blood samples will be collected to determine the Cqtc of ulonivirine.
次要结局
- Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration(Baseline to up to approximately 24 hours)
- Plasma concentration of Moxifloxacin at QTc intervals (Cqtc)(At designated timepoints (up to approximately 24 hours))
- Maximum Plasma Concentration (Cmax) of Moxifloxacin(At designated timepoints (up to approximately 168 hours))
- Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine(At designated timepoints (up to 168 hours))
- Maximum Plasma Concentration (Cmax) of Ulonivirine(At designated timepoints (up to 168 hours))
- Time to Maximum Plasma Concentration (Tmax) of Ulonivirine(At designated timepoints (up to 168 hours))