NCT07600775尚未招募1 期
An Open-label, Phase 1 Study to Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 14
研究概览
简要总结
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI).
The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The main inclusion criteria include but are not limited to the following:
- •Has a diagnosis of untreated latent tuberculosis infection (LTBI)
- •Has no symptoms of active tuberculosis (TB)
- •Has never received treatment for TB or LTBI
- •Other than having LTBI, is in good health
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
- •Has a current or anticipated immunocompromised state
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- •Has a history of cancer (malignancy)
- •Has a history of active TB
- •Has positive test results for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
研究组 & 干预措施
MK-8527 + Rifampin
Experimental
Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin.
干预措施: MK-8527 (Drug)
MK-8527 + Rifampin
Experimental
Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin.
干预措施: Rifampin (Drug)
研究者
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