Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
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.
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy
Pharmacokinetics of ASP7991
Pharmacodynamics of ASP7991
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis|
- The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: Yes ]
- Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: No ]
- iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P [ Time Frame: For 9-16 days after dosing ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Part 1- single administration
The lowest, middle and the highest dose ASP7991 as a single oral administration on non-dialysis day in step 1 to 3 and the highest dose on day of dialysis in step 4.
Experimental: Part 2- repeated administration
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872026
|Study Director:||Medical Director||Astellas Pharma Inc|