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Last Updated: June 18, 2024

CLINICAL TRIALS PROFILE FOR ISAVUCONAZONIUM SULFATE


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All Clinical Trials for Isavuconazonium Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01813461 ↗ 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.
NCT01813461 ↗ 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.
NCT02059590 ↗ 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.
NCT02059590 ↗ A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects Completed Astellas Pharma Global Development, Inc. 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.
NCT03149055 ↗ Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT) Active, not recruiting Astellas Pharma US, Inc. Phase 2 2017-05-04 The purpose of this study is to study the effects of isavuconazole in preventing fungal infections in patients who have had a hematopoietic stem cell transplant (HCT).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isavuconazonium Sulfate

Condition Name

Condition Name for Isavuconazonium Sulfate
Intervention Trials
Healthy Subjects 3
Myeloproliferative Disorder 1
Pharmacokinetics of 14C-labeled Isavuconazole 1
Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate 1
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Condition MeSH

Condition MeSH for Isavuconazonium Sulfate
Intervention Trials
Hematologic Neoplasms 2
Aspergillosis 2
Mycoses 1
Pulmonary Aspergillosis 1
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Clinical Trial Locations for Isavuconazonium Sulfate

Trials by Country

Trials by Country for Isavuconazonium Sulfate
Location Trials
United States 29
Japan 19
Germany 2
United Kingdom 2
Spain 1
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Trials by US State

Trials by US State for Isavuconazonium Sulfate
Location Trials
California 3
Illinois 2
Tennessee 2
New York 2
Florida 2
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Clinical Trial Progress for Isavuconazonium Sulfate

Clinical Trial Phase

Clinical Trial Phase for Isavuconazonium Sulfate
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Isavuconazonium Sulfate
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Isavuconazonium Sulfate

Sponsor Name

Sponsor Name for Isavuconazonium Sulfate
Sponsor Trials
Astellas Pharma Global Development, Inc. 6
Basilea Pharmaceutica International Ltd 3
Jeffrey Jenks, MD, MPH 1
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Sponsor Type

Sponsor Type for Isavuconazonium Sulfate
Sponsor Trials
Industry 11
Other 2
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