An Open-Label Clinical Study to Evaluate the Effects of Multiple Oral Doses of Rifabutin on the Single-Dose Pharmacokinetics of MK-4646 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of MK-4646 in Plasma
研究概览
简要总结
Researchers have designed a new study medicine called MK-4646 as a new way to treat human immunodeficiency virus (HIV). Rifabutin is a medication used to treat tuberculosis (TB).
Researchers want to learn about MK-4646 when taken at the same time as Rifabutin.
They want to:
Measure a person's blood to find out if the amount of MK-4646 in the blood is the same when MK-4646 is taken alone or with Rifabutin Learn about the safety of MK-4646 when taken alone or with Rifabutin and if people tolerate it
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to:
- •Is in good health
- •Has a body-mass index (BMI) between 18 and 32 kg/m2
排除标准
- •include but are not limited to:
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of cancer (malignancy)
研究组 & 干预措施
MK-4646
On Period 1 Day 1, a single oral dose of MK-4646 will be administered.
干预措施: MK-4646 (Drug)
MK-4646 with Rifabutin
Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14.
干预措施: MK-4646 (Drug)
MK-4646 with Rifabutin
Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14.
干预措施: Rifabutin (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of MK-4646 in Plasma
时间窗: At designated timepoints (up to approximately 3 days post dose)
Blood samples will be collected to determine the AUC0-inf of MK-4646 in plasma.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 5 weeks)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 3 weeks)