CLINICAL TRIALS PROFILE FOR ISAVUCONAZONIUM SULFATE

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).

Clinical Trial Conditions for Isavuconazonium Sulfate

Condition Name

Condition Name for Isavuconazonium Sulfate
Intervention	Trials
Healthy Subjects	3
Invasive Aspergillosis	1
Invasive Mucormycosis	1
Myeloproliferative Disorder	1

Condition MeSH

Condition MeSH for Isavuconazonium Sulfate
Intervention	Trials
Hematologic Neoplasms	2
Aspergillosis	2
Neoplasms	1
COVID-19	1

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

Trials by US State

Trials by US State for Isavuconazonium Sulfate
Location	Trials
California	3
Florida	2
Ohio	2
Wisconsin	2
New York	2

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

Clinical Trial Status

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

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

Sponsor Type

Sponsor Type for Isavuconazonium Sulfate
Sponsor	Trials
Industry	11
Other	2