Clinical trials: Aspergillosis Invasive
Invasive Aspergillosis
F901318 Single Ascending Dose Study in Healthy Male Volunteers
F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.
- Trial name
- NCT02142153
- Testing
- F901318
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally .
- Trial name
- NCT03340597
- Testing
- F901318
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole
- Trial name
- NCT01080651
- Testing
- Voriconazole
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Pulmonary Invasive Aspergillosis
Application of an Electronic Nose in the Early Detection of ASpergillosis
The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.
- Trial name
- AENEAS (NCT01395446)
- Where
- Netherlands
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Invasive Aspergillosis
Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects
Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects.
- Trial name
- ORALMAD (NCT02737371)
- Testing
- F901318 Dose level A oral, F901318 Dose level B oral, F901318 Dose level C oral
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
F901318 Multiple Ascending Dose Study
Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase…
- Trial name
- NCT02342574
- Testing
- F901318
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Study of Potential for Interaction of Fluconazole With F901318
This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for…
- Trial name
- NCT02730442
- Testing
- F901318, Fluconazole
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Single Ascending Oral Dose Study of F901318
Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8 subjects.
- Trial name
- NCT02394483
- Testing
- F901318 safety, F901318 tolerability, F901318 pharmacokinetics
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis
Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.
- Trial name
- NCT01614145
- Where
- 3 sites in Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Heidelberg University
Invasive Aspergillosis
Drug/Drug Interactions With F901318
Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and single doses of cyclosporine A and tacrolimus in healthy subjects.
- Trial name
- NCT03095547
- Testing
- cyclosporine A, Posaconazole, Pantoprazole
- Volunteers
- healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis, Acute Leukemia
Diagnostic Study of Combined Biomnarker Testing in Bronchoalveolar Lavage Samples of Immunocompromised Patients
The aim of our prospective and multicentre diagnostic study is therefore to elucidate on the sensitivity and specificity rates of these serologic markers in combination with molecular tools (both an Aspergillus specific and a…
- Conditions
- Invasive Aspergillosis, Acute Leukemia, Biomarkers, Stem Cell Transplantation
- Trial name
- NCT01695512
- Where
- Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Heidelberg University
Aspergillosis Pneumonia, Pneumocystis Pneumonia
Non-invasive Diagnosis of Invasive Pulmonary Aspergillosis by Use of Biomarkers in Exhaled Breath Condensate
In this study, a new, non-invasive method for diagnosis of pulmonary aspergillosis (PA) will be tested in a clinical pilot project.
- Trial name
- NIPA (NCT04358419)
- Testing
- Aspergillus specific proteins in exhaled breath condensate (EBC), Pneumocystis jirovecii DNA in exhaled breath condensate (EBC)
- Where
- Denmark
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Inger Lise Gade
Invasive Aspergillosis
Pharmacokinetics of IV Formulation
Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.
- Trial name
- NCT03076905
- Testing
- F901318
- Volunteers
- healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate
- Trial name
- NCT02680808
- Testing
- Midazolam with F901318
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Invasive Aspergillosis
Evaluation of Immediate Release Tablet
Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast. Evaluation of multiple dose pharmacokinetics and tolerability
- Trial name
- NCT02808741
- Testing
- F901318 SDD, F901318 IR, F901318 IR Fasting
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
Aspergillosis, Candidemia
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.
- Trial name
- NCT00940017
- Testing
- anidulafungin and voriconazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Invasive Aspergillosis
Radiolabelled IV and Oral Metabolism Study of F901318
Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution.
- Trial name
- ADME (NCT02912026)
- Testing
- IV F901318, Oral F901318
- Where
- United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- F2G Ltd
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Background: The immune system is made up of special cells, tissues, and organs that fight infections. Problems with this system may lead to frequent, severe, or unusual fungal infections.
- Conditions
- Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis, CARD9, APECED
- Trial name
- NCT01386437
- Where
- United States
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Invasive Pulmonary Aspergillosis
Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis
The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.
- Trial name
- NCT01247142
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven