A Randomized, Comparative, Open-label Study to Assess the Safety and Efficacy of MK-5592 Compared With Voriconazole in Japanese Subjects With Deep-seated Fungal Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 主要终点
- Number of Participants With an Adverse Event
研究概览
简要总结
The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight >=45 kg
- •Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
- •Female has a negative pregnancy test
- •Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
- •Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.
排除标准
- •Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
- •Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
- •Has long-term inactive aspergilloma not expected to respond to investigational product
- •Is not expected to survive study duration
- •Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
- •Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
- •Is expected to need prohibited medications
- •Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
- •Has known hypersensitivity to any medication
- •Has history of either Torsade de Pointes, myocardial infarction within previous 90 days, has congenital or acquired long QT interval syndrome, or unstable cardiac arrhythmia
- •Has significant liver dysfunction
- •Has liver cirrhosis or cholestasis
- •Has renal insufficiency
- •Has a known hereditary problem of either galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Has acute symptomatic pancreatitis within 6 months of study entry or chronic pancreatitis
- •Has an active skin lesion consistent with squamous cell carcinoma or melanoma, or within prior 5 years a history of malignant melanoma
- •Has known or suspected Gilbert's disease
- •Female is pregnant, or nursing, or intends to become pregnant within 14 days after end of study.
研究组 & 干预措施
Cohort 1: Posaconazole
300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
干预措施: Posaconazole (Drug)
Cohort 1: Voriconazole
300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
干预措施: Voriconazole (Drug)
Cohort 2: Posaconazole
300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days
干预措施: Posaconazole (Drug)
Cohort 2: Voriconazole
300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
干预措施: Voriconazole (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event
时间窗: Up to approximately Day 98
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product is also an AE.
次要结局
- Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)(Day 84)
- Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator(Day 42)
- Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42(Day 42)
- Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84(Day 84)
- Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator(Day 84)