Clinical trials: Pharmacokinetics of FG-4592
Pharmacokinetics of FG-4592, Healthy Subjects
A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects
This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin alone and in combination with multiple doses of…
- Trial name
- NCT02252731
- Testing
- Warfarin, FG-4592
- Where
- Germany
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Normal Renal Function, Impaired Renal Function
A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal Function
For subjects with normal renal function or severely impaired renal function, this study will evaluate the pharmacokinetics of roxadustat and its main metabolites in plasma and urine.
- Trial name
- NCT02965040
- Testing
- Roxadustat
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Adult Subjects
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new…
- Trial name
- NCT03960489
- Testing
- Roxadustat
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
PK of FG-4592, Hepatic Insufficiency
A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects.
- Conditions
- PK of FG-4592, Hepatic Insufficiency, Healthy Subjects
- Trial name
- NCT02161224
- Testing
- FG-4592
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
PK for FG-4592, Healthy Subjects
A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects
This study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly…
- Trial name
- NCT02161796
- Testing
- FG-4592
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Anemia, Hemodialysis
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis
To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.
- Conditions
- Anemia, Hemodialysis, Renal Impairment
- Trial name
- NCT01083888
- Testing
- roxadustat
- Where
- Japan
- Volunteers
- 12 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers
Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single or multiple oral administration in healthy non-elderly adult male subjects.
- Trial name
- NCT00978198
- Testing
- ASP1517
- Where
- Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Chronic Kidney Disease, Renal Anemia
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells.
- Trial name
- NCT05970172
- Testing
- Roxadustat
- Where
- 47 sites in Belgium, Croatia and 17 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.