NCT02174159已完成1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiretroviral Activity of MK-8507 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
- 已完成
- 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
The study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (ART)-naive, HIV-1 infected participants. The hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). Male participants with female partner of childbearing potential agrees to use a medically acceptable method of contraception during the study and 90 days after receiving study drug.
- •Body mass index <=35 kg/m^2
- •Other than HIV infection, baseline health judged to be stable at screening and/or prior to administration of study drug
- •No clinically-significant electrocardiogram abnormality
- •Documented to be HIV-1 positive as determined by a positive enzyme-linked immunosorbent assay (ELISA) or quantitative polymerase chain reaction (PCR) result with confirmation
- •Has a screening plasma Cluster of Differentiation (CD4) T-cell count of >200 /mm^3
- •Has a plasma HIV-1 RNA >= 10,000 copies/mL within 30 days before administration of study drug
- •ART-naive, defined as never having received any ART agent, or have received <=30 consecutive days of an investigational ART agent, excluding non-nucleoside reverse transcriptase inhibitors (NNRTIs), or have received <=60 consecutive days of combination ART, excluding NNRTIs
- •Has not received an investigational agent or licensed ART within 30 days of study drug administration
- •Diagnosed with HIV-1 infection >=3 months before screening
- •Willing to receive no other ART for the duration of the study
- •Has no evidence of mutations conferring resistance to NNRTIs at screening
排除标准
- •Mentally or legally institutionalized or incapacitated, has significant emotional problems, or has a history of clinically significant psychiatric disorder
- •History of clinically significant and not stably controlled abnormalities or diseases
- •History of cancer, with the exceptions of 1) adequately-treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, 2) other malignancies which have been successfully treated >=10 years before screening, or 3) participants who are highly unlikely to sustain a recurrence for the duration of the study
- •History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food
- •Positive for hepatitis B surface antigen
- •History of chronic hepatitis C virus (HCV) unless there has been a documented cure or a negative HCV viral load
- •Had major surgery, or donated or lost >=1 unit (~500 mL) of blood within 4 weeks before screening
- •Participated in another investigational trial within 4 weeks before administration of study drug
- •Unable to refrain from or anticipates the use of any medication beginning 4 weeks before administration of study drug and throughout the trial. Certain medications are permitted.
- •Consumes >3 glasses of alcoholic beverages per day (1 glass is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits). Participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator.
- •Consumes >10 cigarettes per day and is unwilling to restrict smoking to <=10 cigarettes per day
- •Regular user of any illicit drugs or has a history of drug abuse (including alcohol) within 2 years
- •Has an immediate family member who is investigational site or sponsor staff directly involved with the trial
研究组 & 干预措施
Panel A: Ulonivirine 600 mg
Experimental
Single oral dose of ulonivirine 600 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast
干预措施: Ulonivirine (Drug)
Panel B: Ulonivirine 150 mg
Experimental
Single oral dose of ulonivirine 150 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast
干预措施: Ulonivirine (Drug)
Panel C: Ulonivirine <=600 mg
Experimental
Single oral dose of ulonivirine <=600 mg mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast. Inclusion of Panel C in the study, and the dose selected, will be decided pending evaluation of results for Panels A and B.
干预措施: Ulonivirine (Drug)
结局指标
主要结局
Change from Baseline in Plasma HIV-1 RNA
时间窗: 168 hours (7 days) postdose
Number of Participants with One or More Adverse Experiences
时间窗: Up to 21 days postdose
次要结局
- Plasma Concentration of Ulonivirine at 336 Hours Postdose (C336hr)(336 hours postdose)
- Area Under the Plasma Concentration-Time Curve of Ulonivirine (AUC0-168hr)(Up to 168 hours postdose)
- Maximum Plasma Concentration of Ulonivirine (Cmax)(Up to 336 hours postdose)
- Time of Maximum Plasma Concentration of Ulonivirine (Tmax)(Up to 336 hours postdose)
- Plasma Concentration of Ulonivirine at 168 Hours Postdose (C168hr)(168 hours postdose)
- Apparent Terminal Half-Life (T1/2) of Plasma Ulonivirine(Up to 336 hours postdose)
研究者
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