Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

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

The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.