Clinical trials: Isavuconazole
Aspergillosis, Invasive Fungal Infection
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
- Trial name
- NCT00412893
- Testing
- Isavuconazole, Voriconazole
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 527 people
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methadone
Drug Interaction Study of Isavuconazole and Methadone
The primary purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of methadone after single dose administration.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methadone, Healthy Volunteers
- Trial name
- NCT01582425
- Testing
- Isavuconazole, Methadone
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects
The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Safety and Tolerability in Elderly
- Trial name
- NCT01657890
- Testing
- isavuconazole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal…
- Trial name
- NCT00413439
- Testing
- Isavuconazole
- Where
- 4 sites in Germany
- Volunteers
- 18 people
- Sponsor
- Basilea Pharmaceutica
Pharmacokinetics of 14C-labeled Isavuconazole, Healthy Subjects
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
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.
- Trial name
- NCT01813461
- Testing
- 14C-labeled prodrug isavuconazonium sulfate
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Invasive Fungal Disease
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing…
- Trial name
- NCT05630976
- Testing
- Isavuconazole
- Where
- 14 sites in China
- Volunteers
- 70 people
- Sponsor
- Pfizer
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone, Healthy Volunteers
- Trial name
- NCT01597986
- Testing
- isavuconazole, Oral Contraceptive (ethinyl estradiol / norethindrone)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam
Drug Interaction Study of Isavuconazole and Midazolam
The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Midazolam, Healthy Volunteers
- Trial name
- NCT01406171
- Testing
- Isavuconazole, Midazolam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Invasive Mucormycosis, Invasive Aspergillosis
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
- Trial name
- NCT03816176
- Testing
- Isavuconazonium sulfate
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin
Drug Interaction Study of Isavuconazole and Digoxin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin, Healthy Volunteers
- Trial name
- NCT01582412
- Testing
- Isavuconazole, digoxin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects, Pharmacokinetics of Isavuconazole
A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of mycophenolate mofetil (MMF) after single dose administration.
- Conditions
- Healthy Subjects, Pharmacokinetics of Isavuconazole, Pharmacokinetics of Plasma Mycophenolic Acid (MPA), Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)
- Trial name
- NCT01711489
- Testing
- isavuconazole, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.
This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Renal Impaired
- Trial name
- NCT01555866
- Testing
- isavuconazole
- Where
- 3 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Metformin
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Metformin, Healthy Subjects
- Trial name
- NCT01884558
- Testing
- isavuconazole, metformin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Subjects
A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
The purpose of this study is to assess the effect of multiple doses of esomeprazole on the pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole alone and in combination with esomeprazole will…
- Trial name
- NCT02128893
- Testing
- Isavuconazole, Esomeprazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Aspergillosis, Mucormycosis
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food…
- Trial name
- NCT04744454
- Testing
- Isauvuconazole group
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Pfizer
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Atorvastatin
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of atorvastatin.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Atorvastatin, Healthy Volunteers
- Trial name
- NCT01635946
- Testing
- Isavuconazole, atorvastatin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Repaglinide, Pharmacokinetics of Caffeine
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration.
- Conditions
- Pharmacokinetics of Repaglinide, Pharmacokinetics of Caffeine, Healthy Subjects
- Trial name
- NCT02128321
- Testing
- Isavuconazole, Repaglinide, Caffeine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects, Pharmacokinetics of Isavuconazole
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Prednisone in Healthy Adult Subjects
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of prednisolone after single dose administration of prednisone.
- Conditions
- Healthy Subjects, Pharmacokinetics of Isavuconazole, Pharmacokinetics of Prednisolone
- Trial name
- NCT01711827
- Testing
- Isavuconazole, Prednisone
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of…
- Trial name
- NCT04096157
- Testing
- Isavuconazonium sulfate IV, Isavuconazonium sulfate capsules
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Candidiasis, Invasive, Candidemia
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
- Conditions
- Candidiasis, Invasive, Candidemia, Mycoses
- Trial name
- NCT00413218
- Testing
- Isavuconazole, Caspofungin, Voriconazole
- Where
- 113 sites in United States, Argentina and 23 more
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc