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Last Updated: May 21, 2022

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).
NCT03149055 ↗ Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT) Active, not recruiting Memorial Sloan Kettering Cancer Center 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).
NCT03241550 ↗ A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients Completed Basilea Pharmaceutica International Ltd Phase 1 2017-10-02 The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
>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
Hematologic Malignancy 1
Hematological Malignancy 1
Invasive Aspergillosis 1
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Condition MeSH

Condition MeSH for Isavuconazonium Sulfate
Intervention Trials
Aspergillosis 2
Hematologic Neoplasms 2
Mucormycosis 1
Severe Acute Respiratory Syndrome 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
United Kingdom 2
Germany 2
Belgium 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
Astellas Pharma US, Inc. 1
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Sponsor Type

Sponsor Type for Isavuconazonium Sulfate
Sponsor Trials
Industry 11
Other 2
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