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

• Status: Completed
• Trial end date: 2018-01-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Pharmaceutical Solutions; Posaconazole; Voriconazole

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.