Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of MK-4646 Monotherapy in Antiretroviral Therapy-Naïve Participants With HIV-1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Participants with averse events (AEs)
研究概览
简要总结
This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount. The goals of this study are to learn about the safety of MK-4646 and if people tolerate it; and how HIV-1 viral load may decrease after starting to take MK-4646.
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
- •Other than having HIV-1, is in good health
- •Is antiretroviral therapy (ART)-naïve
- •If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening
- •Is willing to receive no other ART prior to Day 8 post-dose of the trial
- •If capable of producing sperm agrees to use contraception
- •If assigned female sex at birth is not breastfeeding
- •A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum), and uses a contraceptive method that is highly effective
排除标准
- •Has acute (primary) HIV-1 infection
- •Has 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
- •Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
- •Has history of cancer (malignancy)
- •Has history of significant multiple and/or severe allergies
- •Tests positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies
- •Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
- •Has received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 14 days following study intervention
- •Is unable to refrain from using protocol specified prohibited medications
- •Is an excessive smoker, or consumes excessive amounts of alcoholic or caffeinated beverages
- •Is a regular user of any illicit drugs or has a history of drug (including alcohol) abuse
研究组 & 干预措施
MK-4646 Panel A
MK-4646 160 mg every 24 hours (q24h) for 7 days
干预措施: MK-4646 (Drug)
MK-4646 Panel B
MK-4646 ≤460 mg q24h for 7 days
干预措施: MK-4646 (Drug)
MK-4646 Panel C
MK-4646 ≤460 mg q24h for 7 days
干预措施: MK-4646 (Drug)
MK-4646 Panel D
MK-4646 ≤460 mg every 12 hours (q12h) for 7 days
干预措施: MK-4646 (Drug)
结局指标
主要结局
Participants with averse events (AEs)
时间窗: 14 days post last dose (Up to Day 23)
Percentage of participants with one or more AEs
Participants who discontinued study medication due to an AE
时间窗: Up to Day 7
Percentage of participants who discontinued study medication due to an AE
Viral load decline of plasma HIV-1 ribonucleic acid (RNA)
时间窗: Predose, 1,2, 3, 4 and 5 days postdose
Time course of plasma HIV-1 RNA viral load decline.
次要结局
- Area under the curve from time 0 to 24 hours (AUC0-24) of MK-4646(Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose)
- Maximum plasma concentration (Cmax) of MK-4646(Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose)
- Concentration at 24 hours (C24) of MK-4646(24 hours postdose)
- Time to maximum concentration (Tmax) of MK-4646(Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose)
- Half life (t1/2) of MK-4646(Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose)