Clinical trials: Pharmacokinetics of Isavuconazole
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.
Hematological Malignancy
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
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.
- Trial name
- NCT03241550
- Testing
- isavuconazonium sulfate - intravenous, isavuconazonium sulfate - oral
- Where
- 16 sites in United States
- Volunteers
- 49 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of BAL4815, Pharmacokinetics of BAL8728
A Study to Assess the Safety and Pharmacokinetics of Isavuconazole in Healthy Chinese Volunteers
The purpose of this study is to evaluate the pharmacokinetic properties of isavuconazole (BAL4815) and the cleavage product (BAL8728) and assess the safety and tolerability after single-dose and steady state (multiple-dose)…
- Conditions
- Pharmacokinetics of BAL4815, Pharmacokinetics of BAL8728, Healthy Volunteers
- Trial name
- NCT01555918
- Testing
- Isavuconazole, Isavuconazole (IV)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Invasive Fungal Infections, Pharmacokinetics
Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
20 patients admitted to the ICU department and receiving isavuconazole as part of standard care for the treatment of fungal infections will be included in the study.
- Conditions
- Invasive Fungal Infections, Pharmacokinetics, Intensive Care Unit
- Trial name
- ICONIC (NCT04777058)
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
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 Bupropion
Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion, Healthy Volunteers
- Trial name
- NCT01635972
- Testing
- Isavuconazole, bupropion hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
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.
Healthy
Drug Interaction Study of Isavuconazole and Cyclosporine
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects.
- Trial name
- NCT01494597
- Testing
- isavuconazole, cyclosporine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Dextromethorphan
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Dextromethorphan, Healthy Adult Volunteers
- Trial name
- NCT01651325
- Testing
- Isavuconazole, dextromethorphan
- 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 Sirolimus in Healthy Subjects
The purpose of the study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of sirolimus after single dose administration.
- Conditions
- Healthy Subjects, Pharmacokinetics of Isavuconazole, Pharmacokinetics of Sirolimus
- Trial name
- NCT01809860
- Testing
- isavuconazole, sirolimus
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Tacrolimus
Drug Interaction Study of Isavuconazole and Tacrolimus
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of tacrolimus after single dose administration.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Tacrolimus, Healthy Volunteers
- Trial name
- NCT01535547
- Testing
- isavuconazole, tacrolimus
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including…
- Trial name
- NCT01565720
- Testing
- Isavuconazole, Moxifloxacin
- Where
- United States
- Volunteers
- 161 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 14C-labeled Isavuconazonium Sulfate, Healthy Subjects
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects
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…
- Trial name
- NCT02059590
- Testing
- Pyridinylmethyl-14C-labeled isavuconazonium sulfate
- Where
- United States
- Volunteers
- 6 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.
Population Modeling of Anti-infective Drugs
Translational PKPD Modeling of Anti-infective Drugs Used in Pediatric Units.
Pharmacokinetic and pharmacodynamic modeling (PKPD) is becoming an essential tool for optimizing pharmacotherapy. Building mechanistic models allows determining the relationship between the dose, concentration, pharmacological…
- Trial name
- NCT05426499
- Testing
- Patients requiring cefotaxime treatment, Patients requiring meropenem treatment, Patients requiring fluconazole treatment
- Where
- 4 sites in Poland
- Volunteers
- 150 people
- Sponsor
- Poznan University of Medical Sciences
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.
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
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 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.