Clinical trials: Pharmacokinetics of Isavuconazole
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.
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.
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 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 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.
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 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 Methotrexate
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of methotrexate.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Methotrexate, Pharmacokinetics of 7-hydroxymethotrexate, Healthy Subjects
- Trial name
- NCT01884636
- Testing
- isavuconazole, methotrexate
- 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.
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 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.
Invasive Fungal Infections, Lung Transplantation
Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients
Isavuconazole is an antifungal medicine used to prevent or treat serious fungal infections in people who have received a solid organ transplant (mainly lung, and also kidney or liver) or a hematopoietic stem cell (bone marrow)…
- Conditions
- Invasive Fungal Infections, Lung Transplantation, Hematopoietic Stem Cell Transplantation (HSCT), Kidney Transplantation
- Trial name
- TRIM-1 (NCT07716878)
- Testing
- Isavuconazole
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Zhibin Xu
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, 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 Lopinavir/Ritonavir
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
The purpose of this two part study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple doses of lopinavir/ritonavir on the…
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Lopinavir/Ritonavir, Healthy Volunteers
- Trial name
- NCT01660477
- Testing
- Isavuconazole, Lopinavir/ritonavir
- Where
- United States
- Volunteers
- 68 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 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.
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
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, 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