Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Healthy Volunteers, Pharmacokinetics of ASP015K
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single ascending doses of ASP015K.
- Trial name
- NCT02141425
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASP2408, Healthy Subjects
A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of…
- Trial name
- NCT02150070
- Testing
- ASP2408
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Fidaxomicin, Healthy Subjects
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects.
- Trial name
- NCT01813448
- Testing
- Fidaxomicin
- Where
- United States
- Volunteers
- 36 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 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 ASP2408
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the…
- Trial name
- NCT02125435
- Testing
- ASP2408
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects, Pharmacokinetics of ASP015K
A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of ASP015K.
- Trial name
- NCT02111317
- Testing
- ASP015K, verapamil
- 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.
Rheumatoid Arthritis, Pharmacokinetics of ASP2408
A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of two dosing regimens of multiple, subcutaneous (sc) injections of ASP2408 in patients with Rheumatoid Arthritis (RA) on Methotrexate…
- Trial name
- NCT02052375
- Testing
- ASP2408
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASP4058, Healthy Subjects
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses
The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects.
- Conditions
- Pharmacokinetics of ASP4058, Healthy Subjects, Food Effect of ASP4058
- Trial name
- NCT01998646
- Testing
- ASP4058
- Where
- 2 sites in United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects, Pharmacokinetics of ASP015K
Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin
The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the pharmacokinetics of rosuvastatin in healthy adult male and female subjects.
- Trial name
- NCT01959399
- Testing
- ASP015K, Rosuvastatin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Bioavailability of ASP015K, Healthy Subjects
A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation.
- Conditions
- Bioavailability of ASP015K, Healthy Subjects, Pharmacokinetics of ASP015K, Food Effect of ASP015K
- Trial name
- NCT01929577
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
Repeat Dose Tolerance Study of Regadenoson in Healthy Subjects
This study is to determine the safety, tolerability, and pharmacokinetics of two or three repeat intravenous (IV) bolus doses of regadenoson administered 10 minutes apart in healthy supine subjects.
- Trial name
- NCT01918995
- Testing
- Regadenoson
- Where
- United States
- Volunteers
- 36 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, 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 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 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 ASKP1240, Healthy Volunteers
Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects
The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.
- Trial name
- NCT01565681
- Testing
- ASP1240
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASKP1240, Pharmacodynamics of ASKP1240
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240
The objective of this study is to assess levels of ASKP1240 in the blood after a single dose given intravenously (IV) or as a subcutaneous (SC) injection.
- Conditions
- Pharmacokinetics of ASKP1240, Pharmacodynamics of ASKP1240, Healthy Volunteers
- Trial name
- NCT01582399
- Testing
- ASKP1240
- Where
- United States
- Volunteers
- 24 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.