Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
Completed
Basilea Pharmaceutica International Ltd
Phase 1
2012-10-01
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole
and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
Completed
Astellas Pharma Global Development, Inc.
Phase 1
2012-10-01
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole
and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
Completed
Basilea Pharmaceutica International Ltd
Phase 1
2013-04-01
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled cleavage product
(BAL8728), in particular the routes of excretion and extent ot metabolism of the cleavage
product following administration of a single intravenous dose of pyridinylmethyl-14C-labeled
prodrug isavuconazonium sulfate (BAL8557). In addition, identify the metabolic profile of
BAL8728 in human plasma, urine and/or feces after a single intravenous dose of
pyridinylmethyl-14C-labeled BAL8557 and evaluate the pharmacokinetics of BAL8728 and BAL4815.
Safety and tolerability after a single intravenous dose of pyridinylmethyl-14C-labeled
isavuconazonium sulfate will also be evaluated.
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