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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR ISAVUCONAZONIUM SULFATE

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Clinical Trials for Isavuconazonium Sulfate

Trial ID Title Status Sponsor Phase 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 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 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 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 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) Recruiting Astellas Pharma US, Inc. Phase 2 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) Recruiting Memorial Sloan Kettering Cancer Center Phase 2 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 Isavuconazonium Sulfate in Pediatric Patients Not yet recruiting Basilea Pharmaceutica International Ltd Phase 1 The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) 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 Sponsor Phase Summary

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Clinical Trial Conditions for Isavuconazonium Sulfate

Condition Name

Condition Name for Isavuconazonium Sulfate
Intervention Trials
Healthy Subjects 2
Hematologic Malignancy 1
Pharmacokinetics of 14C-labeled Isavuconazonium Sulfate 1
Pharmacokinetics of 14C-labeled Isavuconazole 1
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Condition MeSH

Condition MeSH for Isavuconazonium Sulfate
Intervention Trials
Aspergillosis 1
Mycoses 1
Neoplasms 1
Myeloproliferative Disorders 1
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Clinical Trial Locations for Isavuconazonium Sulfate

Trials by Country

Trials by Country for Isavuconazonium Sulfate
Location Trials
Japan 5
United States 3
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Trials by US State

Trials by US State for Isavuconazonium Sulfate
Location Trials
Wisconsin 2
New York 1
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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 1
Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Isavuconazonium Sulfate
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Isavuconazonium Sulfate

Sponsor Name

Sponsor Name for Isavuconazonium Sulfate
Sponsor Trials
Astellas Pharma Global Development, Inc. 4
Basilea Pharmaceutica International Ltd 3
Memorial Sloan Kettering Cancer Center 1
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Sponsor Type

Sponsor Type for Isavuconazonium Sulfate
Sponsor Trials
Industry 9
Other 1
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