NCT01872026

Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis

ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.

Detailed description

To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney disease undergoing hemodialysis. * To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of hemodialysis on PK of single oral administration of ASP7991 in Part 1. * To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.

Conditions

• Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy
• Pharmacodynamics of ASP7991
• Pharmacokinetics of ASP7991

Interventions

Type	Name	Description
DRUG	ASP7991	oral

Timeline

• Start date: 2012-12-26
• Primary completion: 2013-06-26
• Completion: 2013-06-26
• First posted: 2013-06-07
• Last updated: 2024-11-06

Locations

1 site across 1 country: Japan