NCT01152255终止1 期
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK6186 in HIV-1 Infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 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 safety and tolerability of MK6186 and the change from baseline in plasma HIV-1 RNA after seven consecutive days of dosing.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Other than HIV infection, patient's baseline health is judged to be stable
- •Patient is documented HIV-1 positive
- •Patient has not received an investigational agent or licensed ART with in the past 30 days
排除标准
- •Patient has a history of stroke, chronic seizures, or major neurological disease
- •Patient has a history of cancer
- •Patient has used any immune therapy agents or immunosuppressive therapy within the past month
- •Patient requires or anticipates the use of any prescription or non-prescription drugs during the study
- •Patient has a current diagnosis of acute hepatitis, has a history of Hepatitis C or has positive Hepatitis B surface antigen
- •Patient consumes excessive amounts of alcohol (greater than 3 servings per day) or caffeine (greater than 6 servings per day)
- •Patient is an excessive smoker (more than 10 cigarettes per day)
- •Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
研究组 & 干预措施
Panel A - MK6186 40 mg
Experimental
MK6186 40 mg
干预措施: MK6186 (Drug)
Panel B - MK6186 150 mg
Experimental
MK6186 150 mg
干预措施: MK6186 (Drug)
Panel C - MK6186 <=150 mg
Experimental
MK6186 <=150 mg
干预措施: MK6186 (Drug)
Panel D - MK6186 <=150 mg
Experimental
MK6186 <=150 mg
干预措施: MK6186 (Drug)
结局指标
主要结局
Change from baseline in plasma HIV-1 RNA
时间窗: Baseline and Day 7
Safety and tolerability of MK6186 measured by number of clinical and laboratory adverse experiences
时间窗: through Day 21
次要结局
- C(24 hour) of MK6186(Day 7)
研究者
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