Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
Optimer Pharmaceuticals LLC
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus
placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult
participants undergoing hematopoietic stem cell transplantation (HSCT). The primary
hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
Cubist Pharmaceuticals LLC
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will
also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in
healthy Japanese and Caucasian subjects.
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