A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change From Baseline in Plasma HIV-1 RNA
研究概览
简要总结
This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
详细描述
Up to five panels (Panels A-E) of 6 participants each will be enrolled in a sequential manner. In each panel, participants will receive a single dose of MK-8527 up to 50 mg. Historical data from previous single does studies will be used for placebo (control) comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（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: 10 mg MK-8527
Single oral dose of 10 mg MK-8527 capsule after an 8-hour fast
干预措施: MK-8527 (Drug)
Panel B: 3 mg MK-8527
Single oral dose of 3 mg MK-8527 capsule after an 8-hour fast
干预措施: MK-8527 (Drug)
Panel C: 1 mg MK-8527
Single oral dose of 1 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
干预措施: MK-8527 (Drug)
Panel D: ≤50 mg MK-8527
Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
干预措施: MK-8527 (Drug)
Panel E: ≤50 mg MK-8527
Single oral dose of ≤50 mg MK-8527 capsule after an 8-hour fast. Dose level determined by results of previous panels.
干预措施: MK-8527 (Drug)
结局指标
主要结局
Change From Baseline in Plasma HIV-1 RNA
时间窗: Baseline and 168 hours postdose
Blood samples were taken to determine HIV-1 RNA levels at Predose (baseline) and 168 hours postdose. Data were fitted with a longitudinal data analysis (LDA) model containing fixed effects for treatment, time and treatment by time interaction, and a random effect for participant.The change from baseline in plasma HIV-1 RNA in participants administered MK-8527 was calculated and results were compared with historical placebo data.
Percentage of Participants Who Were Discontinued From the Study Due to an AE
时间窗: Up to 28 days
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it is considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE will be summarized.
Percentage of Participants Who Report 1 or More Adverse Events (AEs)
时间窗: Up to 28 days
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it is considered related to the medicinal product. The percentage of participants that reported at least 1 AE will be summarized.
次要结局
- Maximum Concentration (Cmax) of MK-8527-TP in PBMC(Predose and 4, 12, 24, 96, 120, 144, 168, 240, 336, 504, 672 hours or 28 days postdose)
- Time to Cmax (Tmax) of MK-8527-TP in PBMC(Predose and 4, 12, 24, 96, 120, 144, 168, 240, 336, 504, 672 hours or 28 days postdose)
- Concentration at 168 Hours (C168) of MK-8527-TP in PBMC(168 hours postdose for each panel)
- Area Under the Concentration Time Curve From Hour 0 to Last (AUC0-last) of MK-8527-TP in PBMC(Predose and 4, 12, 24, 96, 120, 144, 168, 240, 336, 504, 672 hours or 28 days postdose)
- Area Under the Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-8527-TP in PBMC(Predose and 4, 12, 24, 96, 120, 144, 168, 240, 336, 504, 672 hours or 28 days postdose)
- Area Under the Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) of MK-8527-TP in Peripheral Blood Mononuclear Cells (PBMC)(Predose and 4, 12, 24, 96, 120, 144, and 168 hours postdose)
- Time to Cmax (Tmax) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)
- Apparent Terminal Half Life (t1/2) of MK-8527-TP in PBMC(Predose and 4, 12, 24, 96, 120, 144, 168, 240, 336, 504, 672 hours or 28 days postdose)
- Area Under the Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)
- Area Under the Concentration Time Curve From Hour 0 to Last (AUC0-last) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)
- Area Under the Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)
- Maximum Concentration (Cmax) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)
- Concentration at 168 Hours (C168) of MK-8527 in Plasma(168 hours postdose)
- Apparent Terminal Half Life (t1/2) of MK-8527 in Plasma(Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 168 hours postdose)