Clinical trials: Isavuconazole
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 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 Invasive, Mucormycosis
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric…
- Trial name
- NCT06440915
- Testing
- Theraputic drug monitoring, Isavuconazole
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Children's Medical Center
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
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.
Pulmonary Mucormycosis
Antifungal Drugs in Pulmonary Mucormycosis
Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of…
- Trial name
- NCT06756191
- Testing
- Combination therapy group, Liposomal Amphotericin B
- Volunteers
- 312 people
- Sponsor
- Bin Cao
Mucormycosis
Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study
Background: Mucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole.
- Trial name
- AIM (NCT07191756)
- Testing
- Amphotericin B, Isavuconazole
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Qiu Ye
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
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ketoconazole
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ketoconazole, Healthy Adult Volunteers
- Trial name
- NCT01657838
- Testing
- Isavuconazole, Ketoconazole
- Where
- United States
- Volunteers
- 24 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.
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
Healthy Volunteers
A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants
This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
- Trial name
- NCT05140096
- Testing
- Acalabrutinib, Fluconazole, Isavuconazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acerta Pharma BV
Fungal Infection, Aspergillosis
Isavuconazole in Critically Ill Patients: Efficacy and Safety
Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in…
- Conditions
- Fungal Infection, Aspergillosis, Mucormycosis
- Trial name
- NCT07080359
- Testing
- Isavuconazole treatment
- Volunteers
- 75 people
- Sponsor
- Shanghai 10th People's Hospital
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