Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
Condition: Aspergillosis
MeSH terms: Mycoses; Aspergillosis
Intervention: Posaconazole; Voriconazole
Intervention description: 300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days; 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
Intervention MeSH terms: Voriconazole; Posaconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.